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RELEASE
DATE | HEADLINE: Scroll down to view
headlines
[2009 & 2010 available online; 2008 releases and older available via archives
for BMN subscribers only]
03-05-2010 : Treatment of Humeral Fractures: N.M.B. Medical Applications Ltd. Obtains FDA Clearance for
...
03-02-2010 : Total Artificial Heart Chairman Keynote
Speaker at Medical Devices Summit 2010
02-23-2010 : BELGIAN HOSPITAL TO IMPLANT SYNCARDIA'S
TOTAL ARTIFICIAL HEART
02-11-2010 : California Society of Pediatric Dentists
-- 35th Annual Meeting & Scientific Session Set for Cancun
02-10-2010 : "Medical Device Systems: Strategies for Managing Your Biggest Compliance Challenge"
02-05-2010 : Build New CAPA Investigation Techniques to Meet Tougher FDA Demands in 2010
02-01-2010 : 1ST WORLD CONGRESS ON CONTROVERSIES IN PLASTIC SURGERY DERMATOLOGY TO BE HELD IN BARCELONA SPAIN
01-29-2010 : STERILIZATION STRATEGIES FOR PHARMACEUTICALS, BIOTECH, MEDICAL DEVICES & COMBINATIONAL PRODUCTS
01-28-2010 : SYNCARDIA'S TOTAL ARTIFICIAL HEART
01-25-2010 : FDA Schedules Public Meeting on Pre-market Clearance Process for Medical Devices
01-19-2010 : Successful Artificial Heart Pursued by Many, Achieved by One
01-14-2010 : HAITI:HOW TO CONTACT 70 US ORGANIZATIONS TO PROVIDE HELP
01-04-2010 : 1st WORLD CONGRESS ON CONTROVERSIES IN OPHTHALMOLOGY TO BE HELD IN PRAGUE
12-22-2009 : 19TH ANNUAL NATIONAL HEALTH BENEFITS CONFERENCE & EXPO (HBCE)
12-21-2009 : 1st WORLD CONGRESS ON CONTROVERSIES IN OPHTHALMOLOGY TO BE HELD IN PRAGUE
12-17-2009 : 3rd WORLD CONGRESS ON CONTROVERSIES IN UROLOGY TO BE HELD IN HISTORIC ATHENS
12-16-2009 : SMALL BONE INNOVATIONS, INC. SECURES $30MM CREDIT FACILITY
12-08-2009 : FDA SELECTS QUALITY MANAGEMENT SYSTEM SOFTWARE USED BY SYNCARDIA
12-03-2009 : ExL Pharma's Leading European Digital Marketing & PR Conference to be Hosted @ Bayer Schering
12-02-2009 : Top Turkish Transplant Hospital Begins Certification Training on Syncardia Total Artificial Heart
11-20-2009 : TECHNOLOGY REMEDY FOR AILING HEALTHCARE SYSTEM
11-18-2009 : BY RIDING WITH TEAM SYNCARDIA IN EL TOUR DE TUCSON
11-16-2009 : EUROPLX ANNOUNCES PHARMA PARTNERING 2010 EVENTS
11-12-2009 : DIA (Drug Information Association) 46th Annual Meeting
11-11-2009 : EUROPLX ANNOUNCES PHARMA PARTNERING 2010 EVENTS
11-10-2009 : Bioworld Today launches BIOWORLD INSIGHT
11-09-2009 : DIA (Drug Information Association) In Europe To Host 10th Conference On Electronic Document Management
11-05-2009 : FOR FREEDOM™ DISCHARGE DRIVER TO POWER SYNCARDIA TOTAL ARTIFICIAL HEART
11-04-2009 : PERFORMED AT CLEVELAND CLINIC
11-03-2009 : DIAGNOSIS & TREATMENT OF COMBAT BRAIN INJURIES
10-29-2009 : New Study Finds the Availability of Chiropractic Physician Services Improves the Value of Health Benefit Plans
10-28-2009 : Rennes University Hospital Begins SynCardia Certification Training For The Total Artificial Heart
10-26-2009 : Find Out How 3 Leading Health Plans Are Managing Specialty Drugs Across The Pharmacy & Medical Benefit
10-24-2009 : Cooperative Diagnostics Launches New Diagnostic Test for Chronic Fatigue Syndrome Associated Virus
10-23-2009 : MEDICAL DEVICE COMPANY PARTNERSHIP WITH THE UNIVERSITY OF MEMPHIS ANNOUNCED
10-22-2009 : THEIR PRACTICES WITHIN WEEKS, DESPITE THE RECESSION
10-21-2009 : WHERE MUSCULOSKELETAL DEALMAKERS & EMERGING COMPANIES CONNECT
10-20-2009 : MICROMED SELECTED AMONG TOP COMPANIES IN NATIONAL VC COMPETITION
10-06-2009 : Bioassays: Scientific Approaches & Regulatory Strategies Conference; Nov 2-3 2009
10-05-2009 : Wear Ease Announces New Garments During Breast Cancer Awareness Month
10-05-2009 : Unique Biotech Supply Chain Summit For Marketing & Supply Chain Professionals 60 Top Speakers Announced; South San Francisco CA
10-02-2009 : Drug Information Association (DIA) 7th Canadian Annual Meeting -- Overcoming Global Healthcare Challenges
10-01-2009 : Ash Attia Joins MicroMed Cardiovascular as VP of Asia-Pacific
10-01-2009 : Bioworld Today Releases New Executive Compensation Report 2010
10-01-2009 : EuroPLX To Feature Dynamic Pharma Partnering Focus Concept; Early Registration Deadline is Oct 12
09-30-2009 : Noblitt & Rueland FDA Regulatory Training Hotel Room Block ends this Friday Oct 2; San Francisco Bay Area
09-29-2009 : Medical Product Outsourcing Symposium East (MPO) Agenda Announced; Oct 27-28 2009
09-28-2009 : Register for Medical Device Compliance Congress by Friday 10/3 for Early Bird Rate
09-28-2009 : Global Congress Of Maternal & Infant Health Planned For Barcelona Spain; Early registration deadline is Nov 30 2009
09-25-2009 : Drug Information Association (DIA) to Host Clinical Drug Development Forum; Oct 19-21
09-24-2009 : Dr. Danny Bluestein, Bioengineering Hemodynamics Expert, Joins MicroMed Science Advisory Board
09-24-2009 : Newt Gingrich, Dr. Sanjay Gupta, Michael Moore at HealthAchieve 2009 Conference & Exhibition; Nov 16-18 2009, Toronto Canada
09-23-2009 : 4th Annual Orthopedic Design & Technology Conference & Exhibition, Oct 6-8 2009
09-22-2009 : Total Artificial Heart Manufacturer SynCardia Announces Exclusive Licensing Agreement for AorTech Polymer Heart Valve
09-22-2009 : Biotech Supply Chain Conference For Marketing & Supply Chain Professionals To Feature 55 Top Speakers; South San Francisco CA
09-21-2009 : UC Irvine Center for Health Care Management & Policy Conference Features Expert Speakers From Britain, Canada, Germany & US
09-18-2009 : 2009 Medical Group Compensation & Financial Survey Now Available by American Medical Group Association
09-17-2009 : Medical Device Companies To Partner With University Of Memphis To Recruit Employee-Students
09-16-2009 : Noblitt & Rueland FDA Regulatory Training Seminar Early Registration Deadline is this Friday Sept 18; San Francisco Bay Area
09-15-2009 : Complimentary Cardiology Webinar: Achieving Cardiac Rehab Excellence; Thur Sept 24 2009
09-14-2009 : UC Irvine Center for Health Care Mgmt & Policy Conference; Early-Bird Registration Ends Friday
09-11-2009 : Drug Information Association (DIA) Names New Worldwide Executive Director
09-10-2009 : Biosupply Management Alliance Hosting 2-Day Conference For Marketing & Supply Chain Professionals; South San Francisco; Early Bird Special Ends Sept 30
09-09-2009 : UC Irvine Center for Health Care Management & Policy Conference Set For Oct 01 2009
09-08-2009 : FDAnews Announces FDA Inspections Summit; Featuring 10 FDA Officials; Oct 21-23 2009; Washington DC
09-03-2009 : FDAnews Announces REMS Summit Featuring Dr. Janet Woodcock, Jane Axelrad & Sir Alasdair Breckenridge; Oct 1-2 2009; Washington DC
09-02-2009 : Noblitt & Rueland Announces San Francisco Bay Area Training on Medical Device Compliance Issues; Oct 26-30 2009
09-01-2009 : BioWorld Today Releases New Report: Advancing Vaccines: New Science, New Opportunities
08-27-2009 : HealthAchieve2009 Conference & Exhibition to feature Newt Gingrich, Dr. Sanjay Gupta, Michael Moore; Nov 16-18 2009, Toronto Canada
08-26-2009 : Innovative Tool From The Robert E. Nolan Company To Help Hospitals Plan In Uncertain Times
08-25-2009 : CE in Biotech & Pharmaceutical: 11th CASSS Symposium on Practical Applications for Analysis of Proteins, Nucleotides & Small Molecules; Oct 11-15 2009
08-24-2009 : BioWorld Today Releases New Report: Market-Leading Biotech Drugs Report 2009
08-20-2009 : Prostate Cancer Foundation Funding For Bone Metastasis Research Supports New Drug To Improve Lives Of Prostate Cancer Patients
08-19-2009 : Sigvaris(R) Launches UlceRx Therapy Solution Kit, A Medically-Effective Compression Stocking Kit for Treating Venous Leg Ulcers
08-18-2009 : Complimentary Study: Enable Meaningful Use of the Electronic Health Record
08-14-2009 : $500MM of FDA Funding Derived from User Fees Collected from Industry, reports Biomedical Market Newsletter(R)
08-12-2009 : Register for National Comparative Effectiveness Summit by this Friday Aug 14 2009 for Early Bird Rate
08-11-2009 : Addicus Books Releases Authoritative Consumer Health Titles; Coronary Heart Disease, Macular Degeneration, LASIK, Colon & Rectal Cancer
08-05-2009 : Xanitos Inc Closes $4.0 Million Series D Growth Capital Round
08-04-2009 : Adhezion Biomedical Receives FDA Marketing Clearance For Floraseal(tm) Microbial Sealant
07-30-2009 : New Alliances Announced in the Medical Industry
07-29-2009 : Biotech Industry Symposium Announced: Mass Spec 2009 -- Practical Applications of Mass Spectrometry in Biotech Industry
07-28-2009 : Medical Device Daily State Of The Industry Report 2009 Released
07-27-2009 : FDA Commissioner Margaret Hamburg MD to Keynote 4th FDA Regulatory Symposium; Sept 30-Oct 2 2009; Washington DC
07-21-2009 : Medical Device Daily Releases New Report: Medical Technology & Pandemic Threats: Swine, Avian & SARS
07-20-2009 : Environmental Monitoring: Practical Series Of Medical Product Manufacturing Seminars & Workshops Set By Microrite
07-16-2009 : National Comparative Effectiveness Summit Early Bird Rate ends Friday, July 17 2009
07-16-2009 : Edwards Lifesciences Expands in Switzerland with New Regional Headquarters & Physicians Training Center
07-15-2009 : Next Generation Dx Summit - Moving Assays to the Clinic; Aug 10-12 2009
07-15-2009 : Register for National Comparative Effectiveness Summit by Friday, July 17 2009 for Early/Early Bird Rate
07-14-2009 : Practical Applications of Quality Risk Management; CASSS Strategy Forum; Speakers From Amgen, Biogen Idec & Genentech; Bethesda MD
07-08-2009 : FDA QSR, Inspections, ISO 13485, Auditing, 510(k), CE Marking Training; Disneyland Resort, Anaheim CA
06-30-2009 : Small Bone Innovations, Inc. Raises $144 Million
06-29-2009 : Fraudulent Study, New Disclosure Laws Mean Heightened Regulation & Risk For Medical Device Mfrs; July 16 2009 Webinar
06-22-2009 : Medical & Life Science Illustration For Tradeshow Exhibit Booths Announced
06-18-2009 : Clinical Trial Management Software Company To Exhibit At Drug Information Association (DIA) Annual Mtg, San Diego CA USA
06-17-2009 : JI Solutions, Inc. Announces New Custom Scientific Glassware Service For Lab Testing Requirements
06-09-2009 : 3 New Medical Company Alliances Announced
06-08-2009 : FDA QSR, Inspections, ISO 13485, Auditing, 510(k), CE Marking Training; Disneyland Resort, Anaheim CA
06-04-2009 : Medical Company Automated Export System Compliance Seminars & Workshops Set For S Calif; Comply Or Suffer Civil & Criminal Penalties
06-03-2009 : FDA Enforcement & Intl Compliance Topics to be discussed, Disneyland Resort, Anaheim CA
06-02-2009 : Robert V. Toni Joins Surgical Device Company Adhezion's Board Of Directors
05-29-2009 : Medical Device Labeling Webinar Series By Crimson Life Sciences Begins June 9
05-28-2009 : 17th Annual Medical Device Conference to be hosted by Wilson Sonsini Goodrich & Rosati; San Jose CA
05-26-2009 : Rare Seminar: Understanding Compressed Gases; Equipment, Validation, Safety, Regulations & Testing; Santa Clara CA; June 1 2009
05-19-2009 : Pure H20 Bio-Technologies, Inc. Announces Letter of Intent From H.M. Northcutt Corp For Product Installation
05-18-2009 : EuroPLX Introduces Dynamic Partnering Focus Concept For EuroPLX 41 in Barcelona Spain
05-14-2009 : UC Irvine Posts Taped Webcast Online Of Health Politics & Policies In A New Administration
05-14-2009 : PCF Intl Pharma Compliance Congress to be Broadcast Live & Archived on the Internet
05-13-2009 : In 4 Weeks: 18th Interventional Cardiology Symposium, June 18-20 2009 in Montreal Canada
05-12-2009 : Early Registration Discount Ends Friday For FDA & ISO Regulatory Compliance Courses
05-11-2009 : 20 Days Left To Register: Establishing a Compliant & Effective Environmental Monitoring Program
05-08-2009 : Prostate Health Guidelines Published By Prostate Cancer Foundation
05-07-2009 : New ISO 14971-Certified Risk Management System From Crimson Improves Labeling Translation Accuracy 36%;
05-05-2009 : AHRQ Director Carolyn Clancy & Dr. McClellan to Address Device Executives at 2009 MDMA Annual Meeting
05-02-2009 : Statement From Association for Molecular Pathology on Swine Influenza A (H1N1)
05-01-2009 : Camstar Systems Announces New Product Quality Webinar Series for Life Sciences
04-30-2009 : Proposed Treatment For H1N1 Swine Flu Announced By Energex Systems, Inc.
04-29-2009 : UC Irvine Taped Webcast of 18th Annual 2009 Health Care Forecast Conference, now available online
04-21-2009 : PCF Intl Pharma Compliance Congress Early Bird Rate Ends this Friday April 24 2009
04-20-2009 : Establishing A Compliant & Effective Environmental Monitoring Program; Santa Clara CA USA
04-17-2009 : Prostate Cancer Foundation Funds $1.0 MM In New Creativity Awards for Advanced Research
04-16-2009 : Bridge Laboratories Names Haijun (Lou) Dong as GM of Bridge Labs (China)
04-15-2009 : 18th Interventional Cardiology Symposium, June 18-20 2009, Montreal Canada
04-09-2009 : Serbin Surgery Center Billing Keeps Reimbursement Money Flowing
04-08-2009 : Noblitt & Rueland Announces FDA & ISO Regulatory Compliance Courses, Disneyland Resort, Anaheim CA
04-07-2009 : In 9 Days: The Compelling Evidence-Based Case For Hospital IT Investments: Complimentary Webinar April 16
04-06-2009 : AMGA Launches Interactive Online Medical Group Compensation Database
04-03-2009 : Premium Pharma Strategy Elsevier Conference Digs Into The Meaning Of Big Pharma Mergers For Industry
03-31-2009 : Compelling Evidence-Based Case For Hospital IT Investments: Complimentary Webinar
03-30-2009 : British Medical Journal Group To Introduce Immediate Point of Care Resource at HIMSS 2009
03-27-2009 : Medical Device Labeling Survey By Crimson Life Sciences Confirms Serious Translation Risks
03-26-2009 : Prostate Cancer Foundation Endorses The 21st Century Cancer Alert Act
03-26-2009 : FDAnews Announces 6th Annual Medical Device Quality Congress; June 3-5 2009, Boston MA
03-25-2009 : Medical Product Outsourcing Magazine Announces Complimentary 10-Issue Subscription
03-20-2009 : LUMEDX Launches New Interventional Radiology Software
03-19-2009 : Writing & Enforcing Effective SOPs to Assure GxP Compliance; Boston & Raleigh; Presented by FDAnews & Dills Consulting
03-17-2009 : LUMEDX & Mennen Medical(r) Announce Agreement for a Strategic Cooperation
03-16-2009 : 18th Interventional Cardiology Symposium, June 18-20 2009, Montreal Canada
03-12-2009 : Medical Device Reimbursement Strategies Workshop; Presented by FDAnews & Neocure Group; Boston & Minneapolis
03-09-2009 : Complimentary Webinar: Achieve Measurable Results Through CVIS; March 19 2009
03-06-2009 : Sturgess Company & Advanced Exhibit Methods Win Best of Delta Systems Island Convention Exhibit Design Award
03-05-2009 : CVS.com To Sell FIRSTICE(R) Online to Consumers for Cold Therapy Relief
03-04-2009 : EuroPLX 39 Lisbon Sets New Partnering Conference Benchmarks
03-02-2009 : Disclosure Summit Keynote Address by Senator Grassley on Pharma Disclosure & Transparency open to the public
02-27-2009 : Patient Safety Technical Seminar, March 25 2009; Silicon Valley USA
02-26-2009 : Interventional Cardiology Symposium, Montreal Canada, June 18-20 2009
02-25-2009 : Physicians Continue to Limit Sales-Rep Access, New SK&A Study Confirms
02-24-2009 : FDAnews & LearningPlus Hosting Reportedly Trained or Truly Trained: Developing GMP Training That Works
02-23-2009 : Upcoming CfPIE Courses For Pharma & Why The FDA Wants You To Learn In The Classroom
02-13-2009 : EuroPLX 39 Lisbon Meeting Sold Out
02-12-2009 : FDAnews Classes On Conducting Bulletproof CAPA Investigations
02-11-2009 : Autism and Alzheimer's Disease Seminar - Los Angeles CA; Feb 18 2009
02-04-2009 : Disclosure, Transparency & Aggregate Spend Emerge As Major Compliance Challenges For Pharma & Device Companies
02-03-2009 : Controversies In Childbirth Conference; Ft Worth Convention Center, March 27-29 2009
01-07-2009 : FDAnews & e-SubmissionsSolutions.com Announce New Interactive Workshop; Navigating FDA's New Requirements For ECTD Submissions; Las Vegas & Boston
01-06-2009 : Infrared Sources Improve Capnography & Anesthesia Monitoring, Leister Technologies Has Announced
12-22-2008 : New Patented Laser Plastic Welding Setup To Accommodate Bio-Chip & Microfluidic Assemblies
12-11-2008 : 1st Annual Summit on Disclosure, Transparency & Aggregate Spend for Drug, Device & Biotech Companies Announces Faculty, Agenda & Disclosure
...
12-04-2008 : Controversies In Childbirth Conference; Ft Worth Convention Center, March 27-29 2009
12-03-2008 : Association of Molecular Pathology Urges End to Practice of Granting Patents on Single Genes & Gene Sequences in the Human Genome
12-02-2008 : Retail Based Health Clinics Congress; Bellagio Hotel, Las Vegas NV
11-26-2008 : 2008 Prostate Cancer Retreat Available Online
11-24-2008 : Final Week To Register For ECRI Institute Value-Based Purchasing Conference; Washington DC, Dec 2-3 2008
11-21-2008 : Sturgess Company To Provide Marketing, Advertising & PR Services For Hospital-Acquired Bloodstream Infection Control Device
11-03-2008 : Survey Released: Nurses Agree Collaboration with Hospital Support Service Functions is Key to Patient Safety
10-31-2008 : MDT International Offering US-Based Medical Device Companies Foreign Market Expansion With "Interim Manager" Solution
10-30-2008 : Pharmaceutical Meeting Planners' Summit, Nov 17-18 2008 in New Brunswick NJ
10-29-2008 : Association for Molecular Pathology 14th Annual Meeting & Exhibits Starts Today; Oct 29-Nov 02
10-23-2008 : In 2 Weeks: Age Management Medicine in Las Vegas; Nov 6-9 Conference
10-21-2008 : New Medical Waste Solutions Announced By XMED Disposal Incorporated
10-17-2008 : Deadline Dec 1 2008 To Apply For Innovative Biomedical MBA Program at University of Memphis
10-16-2008 : EPIC Carotid Stent Trial Reveals Lowest Stroke Rates With Distal Protection To Date
10-14-2008 : Oxford Biomedical Research Awarded NIH Contract to Develop Blood Tests for Anticancer Efficacy
10-01-2008 : Medtech Development Acquired By Leading High-Tech Firm, Tronics Microsystems
09-30-2008 : MDT International Providing US-Based Medical Device Companies Foreign Market Expansion To Beat Economic Slowdown
09-25-2008 : Reportedly Trained or Truly Trained: Developing GMP Training That Works; Nov 17-18 2008; Raleigh NC
09-23-2008 : Top FDA officials to address Global Risk Management at Drug Safety Summit; Oct 28-29 2008
09-22-2008 : American College Of Cardiology Certifies Lumedx As An ACC-NCDR Care Registry(TM) Vendor
09-17-2008 : Noblitt & Rueland Announce Las Vegas FDA & ISO Medical Device Training Programs
09-16-2008 : LUMEDX Announces Complimentary Webinar Sept 25: Deliver Highest Quality Care While Meeting Pay-For-Performance Challenges
09-15-2008 : Call for Abstracts - Intl Cartilage Repair Society - ICRS 2009 Miami FL USA
09-11-2008 : New Medical Group Data Finds Financial Losses in Most Regions, Modest Increases in Physician Compensation for Most Specialties
09-09-2008 : 2008 PCF Pharmaceutical Regulatory Compliance Congress & Best Practices Forum Announces Keynote Faculty & Topics Addressed
09-08-2008 : Deliver Highest Quality Care While Meeting Pay-For-Performance Challenges
09-04-2008 : New York Stem Cell Foundation Announces 3rd Annual Stem Cell Research Conference; Oct 14-15 2008
09-03-2008 : Age Management Medicine Group Announces Agenda For Nov 6-9 Conference In Las Vegas
08-28-2008 : LUMEDX Introduces Advanced Multi-Modality, Multi-Vendor, Web-Enabled ECG Management Solution
08-26-2008 : Association For Molecular Pathology To Increase Public Policy Advocacy Role; Retains Govt Relations Consultant
08-22-2008 : Medical Device Companies To Partner With University Of Memphis For Innovative Recruitment Program
08-20-2008 : ExL Pharma Announces Webcast Lineup At ClinXpo -- Pharma's 1st & Only Comp Virtual Conference & Expo, Sept 10 2008
08-19-2008 : ChemSW Scores Highest in Customer Satisfaction on VendorRate
08-13-2008 : Designed for Fast-Paced Cardiac & Vascular Specialties, New Scheduling Software Released Is Flexible Enough for Entire Hospital
08-12-2008 : Michael J. Fox Foundation For Parkinson's Research To Host PD Therapeutics Conference; Chicago IL
08-06-2008 : How Next-Generation Cardiology PACS Is Transforming Image Management, EMR/HIS Integration & Physician Productivity
07-30-2008 : FDAnews Announces 3rd Annual FDA Inspections Summit, Oct 15-17 2008, Bethesda MD
07-26-2008 : Upcoming Medical Meetings #59; 2008 Events
07-24-2008 : FDAnews & Squire, Sanders & Dempsey LLP Announce Doing Business in the EU: A Life Sciences Summit
07-23-2008 : Innovative Pharmaceutical Facility Management HandBook Published
07-22-2008 : National Pharma Audioconference: Analyzing the Newly Revised PhRMA Code
07-21-2008 : 89.5% Of Marketers Surveyed Will Spend As Much Or More In Last Half Of 2008 Than They Did In 1st Half
07-17-2008 : Holographic 3D Medical Animation Arrives: Applications For Medical Device, Medical Education & Pharmaceutical Companies
07-15-2008 : Medical Research Ethics Contest Launched By Coast Independent Review Board LLC
06-26-2008 : Sturgess Company Adds 2 New Medical Companies To Its List Of Clients
06-25-2008 : ChemSW Pre-Release Upgrade Announced For Chemical & Biochemical Inventory Management Systems, Mass Spectral Databases
06-24-2008 : CompuMed, Inc. Teams with OSI Systems, Inc. to Provide Practical & Affordable Bone Density Screening Solutions at the Point-Of-Care
06-23-2008 : Emergo Group Opens New Asian Offices, Helps Medical Device Manufacturers Access Chinese & Japanese Markets
06-11-2008 : Hospital World 2008 Intl Congress; Berlin Germany
06-05-2008 : Cancer Progression Reported Slowed By New Modified Citrus Pectin In New Study
06-03-2008 : Noblitt & Rueland Announces FDA Regulatory & ISO Compliance Courses In Anaheim CA
05-28-2008 : Key Medical Industry, FDA & Congressional Officials to Address Medical Technology Executives
05-15-2008 : The Freakonomics of Health Care at Institute 2008
05-06-2008 : FDAnews Announces Analytical Method Validation Workshop; July 14-16, San Diego CA
05-01-2008 : Leading Electronic Patient Record Conference Announces 2 for 1 Registration Rate, TEPR 2008
04-29-2008 : USC Professor's New Book Explains Scientific Breakthroughs: Stem Cells, Genetic Engineering, Human Cloning
04-28-2008 : 3 Days Left To Register Early For Orthopedic & Spine Driven Ambulatory Surgery Center Conference
04-25-2008 : Early Bird Registration Ends Today For 1st Advamed Intl Medical Device Compliance Congress, May 26-27
04-24-2008 : FDAnews & Industry Directions Launch New Study: Risk Management; Best Practices for Device Profitability
04-23-2008 : Leading Electronic Patient Record Conference Announced, TEPR 2008; May 17-21 2008
04-22-2008 : FDAnews To Host FDA Medical Device Inspections Outside US: Insider Strategies on How to Prepare; June 19-20
04-17-2008 : Medical Instrument Maintenance & Calibration System Software Announced By ChemSW Inc
04-16-2008 : Leading Provider of Embedded Enterprise Intelligence To Host Translational Research Symposium, Boston MA USA
04-15-2008 : FDAnews To Host Reduce Supply Chain Risks Audioconference: How FDA Expects You to Manage Outsourced Suppliers
04-11-2008 : Orthopedics, Spine & Pain Management-Driven ASC Conference; Chicago IL; June 19-21 2008
04-11-2008 : Pharmaceutical Manufacturers: Risk Management Training Announced; Williamsburg VA
04-10-2008 : America's Health Insurance Plans Institute 2008 -- Additional Sessions Announced
04-09-2008 : Sharing Student Health Information Under New FERPA Proposed Rules; 90-minute HIPAA Audio Seminar
04-02-2008 : Sterilization Strategies Are Key Focus For Pharma-Device Firms At Conference; Foster City CA
03-25-2008 : DIA Conference To Examine Challenges Of Patient Adherence In Clinical Trials; Washington DC
03-05-2010 : Treatment of Humeral Fractures: N.M.B. Medical Applications Ltd. Obtains FDA Clearance for Marketing its ENDOLIGN®-made QUANTUM™ Composite Nailing System
Treatment of Humeral Fractures: N.M.B. Medical Applications Ltd. Obtains FDA Clearance for Marketing its ENDOLIGN®-made QUANTUM™ Composite Nailing System
http://www.invibio.com
Stronger & More Elastic than Titanium
Made with ENDOLIGN Composite, from Invibio Biomaterial Solutions
Provides Clear, Scatter-Free, MRI-Compatible Imaging
Thornton-Cleveleys UK -- Medical Industry E-Mail News™ -- March 05 2010 -- CE-approved in 2009 and now cleared by the US Food & Drug Administration (FDA), the QUANTUM™ Humeral Composite Nailing System from N.M.B. Medical Applications Ltd. is an innovative intramedullary interlocking nail made of ENDOLIGN ® (from Invibio® Biomaterial Solutions). ENDOLIGN is an inherently pure and inert composite of continuous carbon fibers in a PEEK-OPTIMA® polymer matrix, to enable patient/surgeon benefits and advance the treatment of long bone fractures.
Regulatory clearance was supported by biocompatibility data, Master File and other biomaterial and technical expertise provided by Invibio. The QUANTUM Composite Nail design combines with ENDOLIGN's unique material characteristics and performance capabilities to challenge the limitations of Titanium and Stainless Steel
According to Elad Einav, N.M.B. Project Manager, Invibio's advanced biomaterial gives the QUANTUM Composite Nail more highly tailored elasticity, higher fatigue strength, and MRI-compatibility, thus helpful in the MRI fracture follow-up. In addition, being radiolucent, the nail enables visualization of the bone fracture site under fluoroscopy and CT during implantation as well as during follow-up. Also, one of the major advantages of PEEK-OPTIMA® is that it has a proven clinical history of safety as a raw material for implantable devices for over 10 years.
As the QUANTUM Composite Nail is radiolucent, a longitudinal marking is incorporated along the nail for easy insertion, positioning and follow-up. Radiopaque markers over the distal interlocking holes enable easier drill trajectory adjustment. A propriety disposable radiolucent drill drive is available as well.
"The QUANTUM Nail is the first nail designed to treat long bone fractures that allows the surgeons to clearly see the fracture site and surrounding structures," Mr. Einav added. "This is especially important in cancer cases where it is critical that the bone structures and soft tissue are visible in follow-up."
ENDOLIGN composite is an excellent material for structural uses and the replacement of metals in high sustained or cyclic load applications requiring blood, bone or tissue contact of more than 30 days. ENDOLIGN offers a unique combination of features and benefits, including:
Excellent tensile strength, stiffness and fatigue behavior allows metal replacement in structural implants.
MRI, CT and X-ray compatibility allows artifact-free postoperative images and clear visualization of the healing site.
Biocompatibility ensures safe, long-term implantation.
Mechanical properties can be tailored to meet a wide range of needs.
Product Images:
Fig. 1. The QUANTUM Composite Nail, made with ENDOLIGN polymer, challenges the limitations of Titanium and Stainless Steel
Fig. 2. Radiopaque longitudinal marking and markers over the distal interlocking holes enable easy insertion, positioning and followup
About Invibio:
Invibio® is a global leader providing high performance biomaterials, advanced technical research and consultative solutions to medical device manufacturers across a wide range of markets. The company provides medical device manufacturers with PEEK-OPTIMA® polymer and compounds, MOTIS™ polymer, ENDOLIGN® composite and PEEK-CLASSIX™ polymer for the development of long- and short-term implantable medical devices.
About N.M.B:
N.M.B. Medical Applications Ltd. (formerly Disc-O-Tech Medical Technologies Ltd.), is engaged in developing, manufacturing and marketing of innovative solutions for the fixation of long bones fractures. The company uses its cumulative knowledge and expertise in the field of orthopedics to develop products, which enhance the quality of life of patients and are more user-friendly for surgeons. The company has a full line of trauma products, including the Fixion® Intramedullary Nailing family that comprises expandable metal nails. The Fixion products are marketed worldwide, with over 60,000 implantations performed thus far.
SOURCE:
Invibio
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03-02-2010 : Total Artificial Heart
Chairman Keynote Speaker at Medical Devices Summit 2010 at Medical Devices
Summit 2010
DR. MARVIN SLEPIAN GIVES KEYNOTE SPEECH ON SYNCARDIA'S TOTAL ARTIFICIAL HEART AT MEDICAL DEVICES SUMMIT 2010
SynCardia Chairman Addresses Winning FDA Approval & Medicare Reimbursement for the World’s Only Approved Total Artificial Heart
http://www.syncardia.com
Tucson AZ USA -- Medical Industry E-Mail News™ -- March 02 2010 -- On March 2, Dr. Marvin Slepian, world-renowned interventional cardiologist and co-founder and chairman of SynCardia Systems, Inc., manufacturer of the SynCardia temporary CardioWest™ Total Artificial Heart, was the keynote speaker at the Medical Devices Summit 2010 held in Boston. The conference highlighted key strategies for regulatory compliance, including the latest tips for streamlining the medical device approval process.
“In 2004, SynCardia’s Total Artificial Heart became the first and only Total Artificial Heart in the world to receive Pre-Market Approval from the FDA,” said Dr. Slepian. “In 2008, SynCardia also successfully petitioned the Centers for Medicare & Medicaid Services to reverse its 1986 national non-coverage policy for artificial hearts and approve reimbursement through the highest paying Diagnostic Related Group codes.”
In addition to discussing the development and clinical use of the Total Artificial Heart, Dr. Slepian also addressed the future of SynCardia technologies currently under development, including its new family of pneumatic drivers for powering the Total Artificial Heart and the smaller 50cc Total Artificial Heart designed for women and patients of smaller stature.
Dr. Slepian is Professor of Medicine (Cardiology), Director of Interventional Cardiology and Director of the Tissue Engineering Lab at the University of Arizona. He has founded numerous medical device companies and has served as acting CEO and Board Member of several medical device startups. Additionally, Dr. Slepian has conducted extensive research, development and pre-clinical investigation of novel cardiovascular therapeutic methods and devices, and is the holder of more than 25 issued and 41 filed patents.
SOURCE:
SynCardia Systems Inc
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02-23-2010 :
BELGIAN HOSPITAL 50th TRANSPLANT CENTER TO BEGIN CERTIFICATION TRAINING
TO IMPLANT SYNCARDIA'S TOTAL ARTIFICIAL HEART
-- OLV Hospital Aalst Will Be 1st Center in Belgium to Become Certified
to Implant the World’s Only Approved Total Artificial Heart
http://www.syncardia.com
Tucson AZ USA -- Medical Industry E-Mail News™ -- Feb 23 2010 -- On Feb. 25 & 26, the surgical team from Onze Lieve Vrouw (OLV) Hospital Aalst, led by surgeons Ivo Deblier, MD, and Karl Dossche, PhD, and accompanied by anesthesiologist Koen De Decker, MD, will become the first hospital in Belgium and the 50th hospital in the world to complete the first phase of certification training to implant the SynCardia temporary CardioWest™ Total Artificial Heart.
“The Total Artificial Heart has no equal in the world of mechanical circulatory support,” said Mary Pat Sloan, Vice President of Global Training and Customer Support for SynCardia Systems, Inc. “It is the only device that replaces both failing heart ventricles and pumps up to 9.5 L/min through both sides of the heart to help the patient recover faster.”
OLV Hospital performs approximately 1,300 heart operations, 700 vascular operations and 180 lung operations annually. The hospital performed its first heart transplant in 1988. It implanted its first defibrillator in 1990 and its first mechanical circulatory support device as a bridge to transplant in 1995.
Fifty of the world’s finest transplant hospitals, surgeons and medical teams have become, or are training to be, SynCardia Certified Centers. These hospitals represent 12 different countries from around the world: the U.S., Canada, France, Germany, Italy, Austria, Sweden, Switzerland, Lithuania, Turkey, Australia and Belgium.
To become a SynCardia Certified Center, hospitals must apply for and complete a rigorous, four-phase training program, including the first proctored implant by an experienced Total Artificial Heart surgeon.
SynCardia Systems, Inc. is the Tucson-based manufacturer of the world's only FDA, Health Canada and CE approved Total Artificial Heart: the SynCardia temporary CardioWest™ Total Artificial Heart. There have been more than 800 implants of the Total Artificial Heart, accounting for more than 180 patient years of life on the device.
Originally used as a permanent replacement heart, the Total Artificial Heart is currently approved as a bridge to human heart transplant for people dying from end-stage biventricular failure. The Total Artificial Heart is the only device that provides immediate, safe blood flow of up to 9.5 L/min through both ventricles.
For additional information, please visit: http://www.syncardia.com
SOURCE:
SynCardia Systems Inc
http://www.syncardia.com
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02-11-2010 : California Society of Pediatric Dentists • 35th Annual Meeting & Scientific Session Set for Cancun
•
California Society of Pediatric Dentists • 35th Annual Meeting & Scientific Session Set for Cancun
http://www.cspd.org/calendar/show.asp?event_ID=132
Early registration extended to Feb 28 2010
April 08-11 2010 -- Cancun Mexico at Fiesta Americana Coral Beach Resort, a AAA 5-Diamond Property
Carmel CA USA -- Medical Industry E-Mail News™ -- Feb 11 2010 -- On April 08-11 2010, the California Society of Pediatric Dentistry is hosting its 35th annual meeting and scientific session in beautiful Cancun Mexico, the organization announced today.
Noted Topics & Speakers To Include:
Caries & Prevention, Dr. John Featherstone, UC San Francisco
Infant & Perinatal Oral Health, Dr. Francisco Ramos, UC Los Angeles
Composite Resins & Adhesives, Dr. Joel Berg, University of Washington
Pulp Therapy, MTA, & Trauma, Dr. Leif Bakland, Loma Linda University
Dental Technology & Practice Management, Ms. Debra Quarles, IPS
New Dentist Lectures: Dr. Lisa Brennan, Dr. Jeff Huston, Dr. Gary Sabbadini, Dr. David Kang & Dr. Neidre Banakus
Why You Should Attend:
Earn Continuing Education Units while having fun in the sun. Relax, listen, and learn from some of dentistry's greatest speakers. Travel to a land of idyllic beauty, where luminous white sandy beaches stretch into prismatic blue waters. Visit a new side of Mexico where pristine beaches bathe the shores of a land that is proud to honor its Mayan heritage. Experience tropical mangrove preserves surrounded by the second largest coral reef formation in the world.
SAMPLE SESSIONS:
For full schedule, session descriptions, dates & time visit: http://www.cspd.org/calendar/show.asp?event_ID=132
PALS -- Full Course, April 7-8
Raedelle Wallace MSN, ARNP -- Clinical Education Coordinator, Kennewick General Hospital American Heart Association PALS Instructor & PALS Regional Faculty. Ms. Wallace has extensive critical care experience in the care of pediatric patients.
The Caries Balance: Management by Risk Assessment, April 9
John Featherstone PhD -- Dean of the School of Dentistry, UCSF & Professor of Preventive & Restorative Dental Sciences.
His research over the past 35 years has covered several aspects of cariology, including fluoride mechanisms of action, de- & remineralization of teeth, apatite chemistry, salivary dysfunction, laser effects on dental hard tissues, caries prevention, microbiology of cariogenic bacteria, caries risk assessment and caries management.
Infant & Perinatal Oral Health, April 9
Francisco J. Ramos-Gomez DDS MS MPH -- Full Professor, Section of Pediatric Dentistry, UCLA; & Graduate Program Director for UCLA's Pediatric Community Health Advance Training (CHAT) program in Venice CA.
Practice Management & Dental Technology, April 9
Debra Quarles -- Ms. Quarles is a change-maker and her innovative ideas and concepts create extraordinary results. Ms. Quarles is a practice consultant who prefers to call herself a coach. She has worked with Innovative Practice Solutions, Inc. for more than 12 years and has helped hundreds of dental and medical professionals remember why they love their work. In her "Practice Management & Dental Technology" session, attendees will be taught how to think like a "practice coach." They will learn how to assess the systems currently in use in their practices & be given benchmarks, dialog and creative ideas to increase effectiveness and deliver excellent customer service. Utilizing different office software and digital radiography programs and incorporating them in the dental practice to work more efficiently and effectively will be discussed with these systems.
New Dentists' Program:
"Practice Transition" -- Dr. Lisa Brennan
"How to Run an Efficient & Profitable Practice" -- Dr. Gary Sabbadini
"Get 'em in Early" -- Dr. Jeff Huston
"High-Tech Dental Practice: Going Paperless" -- Dr. David Kang
"Sweat the Small Stuff: Hints & Tips for Opening a New Practice” -- Dr. Neidre Banakus
Other Program Highlights:
“From Glass Inomer to Resin Composite: Restorative Options for Children”
Joel H. Berg DDS MS -- Professor & Chapman Chair for Oral Health, Dept. of Pediatric Dentistry, University of Washington.
Board certified pediatric dentist, and trustee of the AAPD. He has authored many manuscripts, abstracts and book chapters on restorative materials for children and other work related to biomaterials. His current research interests include the development of dental caries prevention programs using risk assessment models and early childhood oral health.
"The Why, What, Where & How of Pediatric Dentistry"
Dr. Gustavo Pardo, Past President, Mexican Academy of Pediatric Dentistry, Diplomate of ABPD
"Dental Trauma, Pulp Therapy & MTA"
Leif Bakland DDS -- Professor of Endodontics, Loma Linda, School of Dentistry. Graduate, School of Dentistry, Loma Linda University. After 8 years of general practice, entered the endodontic residency at Harvard School of Dental Medicine / Forsyth Dental Center in Boston. Dr. Bakland has been involved in education, research, and professional organizations for over 40 years. His research and publication interests include endodontics & dental traumatology.
Conference Location:
The Fiesta Americana Coral Beach Resort is recognized as one of the few AAA five-diamond resorts in the Caribbean. Experience an internationally renowned resort & be welcomed with world-class service. The Fiesta Americana Coral Beach Resort provides an impeccable setting from serenity to energetic sounds of jazz. Lounge in the lobby bar where guests can gather to savor a variety of tapas, fine wine & spirits, or even authentic Cuban cigars. Guest rooms are all junior suites with ocean views, marble floors, sunken living areas & private terraces to the sea. Master suites are available which are ideal for small party socializing & entertaining. Beach Presidential suites of astounding opulence and tasteful elegance have awesome views. The Fiesta Americana Coral Beach Resort is a destination that cannot be missed.
Passports:
Passports that are up to date will be necessary.
Please be sure to provide your Passport and Immigration Card upon check-in at the hotel.
Early Bird Registration Deadline:
Early registration has been extended to Feb 28 2010.
http://www.regonline.com/Checkin.asp?EventId=744046
CMEs:
A total of 24 CE units are available. CSPD will present a series of Web-Based Pediatric Dental Continuing Education Lectures which feature streaming audio and video. These courses are designed to educate dental professionals on the wide range of subjects essential to pediatric dentistry. Select and purchase a course to view, take the exam and receive a certificate-of-completion, all online. Lectures are approved for CA, AGD, Florida and ADA CERP CE credits.
Community Service Project:
Oral hygiene instructions and dental screenings for Cancun orphans.
Fun Activities:
Ride on a zipline through a jungle and visit a cenote, a deep water filled sinkhole formed by water percolating through soft limestone.
An unforgettable experience for the first-time visitor.
Enjoy Taste of Cancun, a culinary experience. Watch the Caribbean sunset while imbibing a tropical drink at the Aqua. Try an Aquatini.
Spend the day at Tulum visiting the Mayan ruins and stroll down the streets of Playa de Carmen andhave lunch.
About Cancun:
Cancun offers a marvelous ensemble of natural beauty, theme parks, ecological reserves, white sandy beaches, and calm Caribbean islands and sea. It is also home to the second largest reef in the world filled with an infinite variety of multicolored fish. Besides offering sun, sand and sea, this destination offers you the possibility of participating in countless activities.Scuba diving, snorkeling, and fishing are just a few of the activities that you just can't miss on your trip to this great resort destination. Mujeres Bay and the Caribbean Sea allow you to enjoy these activities in a safe and fun way. Dare to enjoy an underwater world that will astound you.
If you enjoy adventure sports, there are many tours that leave from Cancun for different locations: explore large caves, hike through the jungle, bike along barely accessible trails, take an aerial tour on a zipline or rappel down into a lost "cenote." Ecotourism tours are available to take you to small Mayan communities where you can interact with these peaceful inhabitants.
In the afternoons and at night, this destination offers numerous opportunities to experience its great shopping centers, dine in one of its prestigious restaurants, or stay out until all hours of the night in any one of its world famous bars or night clubs. Cancun will always be able to offer you a memorable experience, regardless of your age, taste, or preferences.
About CSPD:
The California Society of Pediatric Dentists was founded in 1975, represents the specialty of Pediatric Dentistry in California and is dedicated to education, practice and research in the specialty of pediatric dentistry. CSPD is comprised of over 700 California pediatric dentists along with a number of associate colleagues from other states. The society provides liaison with other health care organizations, government entities, and private agencies concerned with the dental health of children, adolescents, and individuals with special health care needs.
CSPD became a state component of the American Academy of Pediatric Dentistry in 1983 and is currently the largest state component of AAPD, comprising almost 10% of AAPD membership. CSPD maintains an active role in the AAPD with members serving over the years as AAPD presidents, committee chairpersons and members of the Board of Trustees. Our component is one of the most active and progressive in the nation.
About The Pediatric Dentist:
The Pediatric Dentist is the specialist who is dedicated to the oral health of children from infancy through the teen-age years. The very young, pre-teens, and teenagers all need different approaches in dealing with their behavior, guiding their dental growth and development, and helping them avoid future dental problems. The pediatric dentist is best qualified to meet these needs.
Pediatric dentists have had special training, which allows them to provide the most up-to-date and thorough treatment for a wide variety of children's dental problems. They are trained and qualified to treat patients with special health care needs. Because of this specialized training and commitment to comprehensive oral health, many parents wisely choose a pediatric dentist to treat their children.
SOURCE: California Society of Pediatric Dentists
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02-10-2010 : "Medical Device Systems: Strategies for Managing Your Biggest Compliance Challenge"
FDAnews Announces Medical Device Complaint Systems Virtual Conference
"Medical Device Systems: Strategies for Managing Your Biggest Compliance Challenge"
http://www.fdanews.com/MedicalDeviceVC
Wednesday, Feb 24 2010 • 10:00 am -- 5:00 pm EST
Presented by FDAnews
Falls Church VA USA -- Medical Industry E-Mail News™ -- Feb 10 2010 -- Are you ready for eMDRs? The long awaited, and hotly contested, proposed rule on eMDRs appears to be getting closer to final approval. The extended comment period ended Nov 16 and 2010 looks like the year we’ll see the final version. Industry estimates suggest it will cost $50 million to $80 million to comply.
But eMDR is not the only concern. Warning letters and 483s are already raining down on companies whose complaint management systems fall short of FDA standards.
DID YOU KNOW:
That all complaints under 21 CFR 820.198 and ISO 13485 are not equal? Some are serious, some not so. Do you know how to tell one from the other?
That the FDA can ding you for failing to train front-line employees to spot complaints? Customer service staff, sales and field agents are your eyes and ears. Have you tuned them in?
Under 21 CFR 806 you must keep records of all corrections and removals — even those not required to be reported. Sound easy? Then why so many warning letters on the topic?
Clearly, complaint systems are a complex, fast-changing subject, with big penalties if you get things wrong. Isn’t it worth a day of your time to straighten matters out?
Mark your calendar now for Wednesday, Feb 24 2010. It’s an all-day skull session featuring the latest thinking of FDA insiders -- solutions from industry colleagues who face the challenges you face -- and consultants who deal with dozens of companies like yours.
No need to pack your bags for this conference -- it’s virtual. Just plan to spend the day near a computer screen. And if you’re not available the day of the conference, you can still choose the Audio CD and transcript, including Q&As and full sets of presentation materials, available four weeks later. Or dial up the 24/7 ENCORE™ Presentation for a recording of the proceedings plus all seminar materials. There’s no limit on the number of dial-in participants and the 24/7 ENCORE™ is available for three weeks -- 24/7, of course.
CLEARING UP THE CONFUSION ON MDR:
Deborah Kacera, Senior Project Manager at Pilgrim Software, helps you prepare for the coming electronic Medical Device Reporting (eMDR) regulations, including best practices for complaint recording, investigations, root cause analysis, resolution and reporting. She has provided recommendations to the FDA regarding additional and adjusted content for eMDR document requirements and input into coding changes to increase eMDR submission process efficiency. Kacera has been invited to participate in the FDA’s Problem/Adverse Event Codes Working Group.
Kacera is joined by five other expert panelists who touch on every important aspect of medical device complaint systems in an information-packed day:
Consultant Susan Reilly, Reilly & Associates LLC, analyzes the different definitions of “complaint” under 21 CFR 820.198 and ISO 13485.
Tatyana Chorni of Philips Healthcare tells how to use statistical techniques -- scatter plots, check sheets, Pareto charts, cause-and-effect diagrams -- to create and maintain procedures for device servicing in compliance with 21 CFR 820.200.
John Talarico of Delcath Systems shows how to train employees to recognize and react to complaints in ways that meet FDA requirements.
Edward Wilson, Partner, Hogan & Hartson, will help you cut through the confusion, explaining legal intricacies in plain English.
Consultant Dan O’Leary* of Ombu Enterprises, shows how to live up to 21 CFR 806 reporting responsibilities -- key essentials that will help you get ready for inspections and avoid mandatory recalls.
* Dan O'Leary, virtual conference chair, has 30+ years of experience in quality, operations and program management in the medical device and clinical lab industries, as well as aviation and defense. His firm, Ombu Enterprises LLC, serves small manufacturing companies with advice and counsel on operational excellence and regulatory compliance.
Worth Your Time ... and Then Some
Want specifics? Here’s a small sampling of topics and items on the virtual conference agenda:
How to evaluate each complaint to determine if an MDR is required
6 key elements the FDA requires in a service report and which records must be kept
Understanding the requirements that make statistical analysis mandatory
What service people should look for to identify consumer complaints
How to train sales personnel to recognize and report complaints
Terms, definitions and forms that firms are responsible for when submitting MDRs
Who is qualified to make medical judgments and who the FDA will deem appropriate
Distinguishing between a correction and a removal and defining terms such as “market withdrawal,” “routine servicing” and “stock recoveries”
Which documents your firm needs to keep and when reports are required for a correction or removal
And much more
No Planes, No Trains, No Automobiles
You’d gladly (or maybe grudgingly) get on a plane and check into an unfamiliar hotel to attend a conference so timely. Good thing you don’t need to.
Stress-free. No airport nightmares, no hotel snafus, no waking at 4 a.m. to catch an early flight. You never leave your building. You don’t even need to leave your desk.
Interactive. Plenty of opportunities to ask questions and get involved. Send in queries via e-mail -- you’ll have answers before you log off.
Up-to-the-minute. Every speaker operates in the real world, in real time. If something important happens on conference morning, you’ll hear about it from a speaker before the sessions end.
Great value. Spread the word. There’s no limit on number of attendees per site. One low registration fee covers them all.
Here’s How It Works:
24 hours prior to the conference Wednesday, attendees will receive all presentations.
Then just log on to the conference website and dial a toll-free number, both provided in your registration confirmation.
Who Will Benefit:
Quality assurance managers and staff
Regulatory affairs managers and staff
Complaint management staff
Risk management specialists
Design and development managers
Project managers
Process validation specialists
Auditors
Consultants/service providers
Manufacturing directors and supervisors
Personnel new to the industry
Risk management specialists
Sales/marketing personnel
Conference Details:
Medical Device Complaint Systems: Strategies for Managing Your Biggest Compliance Challenge -- A Virtual Conference
Wednesday, Feb 24 2010 • 10:00 am -- 5:00 pm EST
Tuition: $1,297 per site -- includes virtual conference registration and audio CDs and transcripts
Program Guarantee:
You must be 100% satisfied with this learning opportunity or we'll refund your entire tuition, or extend a credit to a future FDAnews conference.
Cancellations/Substitutions:
Virtual Summit registrations may not be cancelled. Registrants may substitute the 24/7 ENCORE™ audio and Web-based presentations for the live virtual conference at any time. Please contact Customer Service to make any substitutions. No-shows will automatically be sent the 24/7 ENCORE™ login information and speakers’ presentations.
About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.
SOURCE:
FDAnews
300 N Washington St Ste 200
Falls Church VA USA 22046-3431
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02-05-2010 : Build New CAPA Investigation Techniques to Meet Tougher FDA Demands in 2010
CONDUCTING BULLETPROOF CAPA INVESTIGATIONS -- ADVANCED:
Build New CAPA Investigation Techniques to Meet Tougher FDA Demands in 2010
http://www.CAPAworkshop.com
Presented by FDAnews & Immel Resources
March 24-25 2010 -- Raleigh NC
Sept 29-30 2010 -- San Juan PR
Falls Church VA USA -- Medical Industry E-Mail News™ -- Feb 05 2010 -- The FDA's new enforcement plan makes one thing clear: Developing a successful CAPA program has never been more important. But creating an FDA-proof CAPA has never been easy.
If only you could pick the brain of someone who is coping successfully with CAPA -- the best and the brightest, an industry leader who has devised programs, procedures and solutions that have put companies out in front with the FDA. Well, now you can.
FDAnews and Immel Resources are offering an advanced version of our previous CAPA investigations class -- designed to meet tough FDA scrutiny in 2010.
IN THIS ADVANCED, INTERACTIVE WORKSHOP YOU WILL:
Learn how to respond to the FDA and implement effective CAPA to prevent regulatory action and get a closeout letter
Get an insider view of the FDA's own training program for investigators -- portions of the Reid Technique DVD will be reviewed during the course
Review lessons learned from nine years of FDA warning letter citations on CAPA investigations
Learn key problem-solving techniques to break down a problem into its component parts: CIA, Kepner-Tregoe and FMEA
Receive a course workbook complete with charts, forms, manuals and guidance
Interact with colleagues to participate in 14 interactive exercises
ADDITIONAL WORKSHOP BENEFITS INCLUDE:
Gain valuable strategies for performing in-depth interviews and determining individuals responsible for an event
Using proven law enforcement techniques, discover best practices for training, assigning and managing your lead investigators
Benchmark current best practices in CAPA and investigations with your peers
Learn 22 great investigative tools you can teach to all your employees
Obtain sample forms for conducting investigations and case reviews
Review required FDA notifications, such as field alerts, medical device reports, biologic product deviation reports, adverse events, serious adverse events, recalls, corrections and removals
Understand the four elements of a well-written report and how to coach employees on report writing
REGISTER NOW:
Conducting Bulletproof CAPA Investigations -- Advanced: Interactive Workshop on Investigating Techniques to Meet Regulatory Scrutiny
http://www.CAPAworkshop.com
MEET YOUR INSTRUCTOR:
Barbara K. Immel, a published author and nationally known speaker, is president of Immel Resources LLC and editor of the Immel Report.™ She has 26 years of industry experience working in corporate quality assurance, compliance, training, documentation, and labeling. Barb's experience includes more than 12 years with Syva Company, Chiron Corporation, and Syntex Corporation. Barb is the chairperson of the annual FDA Inspections Summit hosted by FDAnews.
Barb has presented at hundreds of national and international industry meetings, and has taught well-respected GMP classes for more than 20 years. She has created and taught biotechnology and drug development courses for UC Berkeley Extension, served as an instructor for the Pharmaceutical and Biotechnology Quality Assurance Course for the University of Wisconsin at Madison, served as a panelist at the Stanford Professional Publishing Course, and taught the tutorial on FDA's Phase 1 proposals at the International GMP Conference at the University of Georgia. Barb has been teaching well-respected courses on writing reports for deviations and failure investigations, and on conducting CAPA investigations, for the past 8 years (2000-2008).
WHO WILL BENEFIT:
CAPA managers
Compliance officers
Training managers
GCP, GLP and GMP professionals
QA/QC managers and directors
Quality engineers
Regulatory affairs managers
Anyone wishing to improve an organization's CAPA activities and investigations
TOOLS & REFERENCE MATERIALS:
Your valuable course materials book is packed with tools and reference materials you can put to use right away, including:
FMEA chart
How to respond to FDA Form 483s and warning letters
Comprehensive CAPA bibliography and recommended reading list
Current FDA regulations
Pertinent guidance documents
Three articles on problem investigations
FDA inspection manuals
FDA's out-of-specification guidance
ICH E6 good clinical practice guidance
Recent FDA Form 483s or EIRs
Pertinent FDA warning letters
16 great interviewing tips
Two articles on CAPA
FDA field alert, MDR, BPDR, AE forms
FDA recall guidance
Writing an executive summary
Fishbone cause and effect diagrams
Tips on documenting/presenting root causes
Preventive action flowchart
Sample interview forms
Sample audit "checklists"
Writer's questionnaire
Speaker's questionnaire
On customer complaints
CAPA checklist
Mock failure investigation reports
Sample investigation plan
Sample case review form
Tips on conducting out-of-specification investigations
Compliance tips/best practices
WHAT PAST ATTENDEES HAVE TO SAY:
"Very thorough. Great real-life experiences. Enjoyed this course, the content and especially Barbara.
Her wealth of knowledge and presentation style welcomes all levels of personnel in an engaging environment."
Charla Lee
Supervisor, Incident Team, Talecris Biotherapeutics
"Very, very knowledgeable in what she is teaching. Excellent presence.
I liked the group work and the interactions with others and their experiences."
Jason Ferens
Quality Engineer, Fort Wayne Metals
"Barbara was very knowledgeable. The way the class was structured with the interactive exercises, videos, etc. made the days go fast.
I got a lot of useful information to bring back to my company. Talking to peers gave insight into other company's processes."
Loren Jennings
Quality Systems Coordinator, Fujirebio Diagnostics
CONFERENCE DETAILS:
Conducting Bulletproof CAPA Investigations -- Advanced
March 24-25 2010 -- Raleigh NC
Sept 29-30 2010 -- San Juan PR
Tuition: $1,897 per attendee
4 EASY WAYS TO REGISTER:
Online: http://www.CAPAworkshop.com
By phone: 888-838-5578 or 703-538-7600
Fax: 703-538-7676
Mail to: FDAnews
300 N Washington St Ste 200
Falls Church VA USA 22046-3431
PROGRAM GUARANTEE:
You must be 100% satisfied with this learning opportunity or we'll refund your entire tuition, or extend a credit to a future FDAnews conference.
CANCELLATIONS/SUBSTITUTIONS:
Written cancellations received at least 21 calendar days prior to the start date of the event will receive a refund -- less a $200 administration fee. No cancellations will be accepted - nor refunds issued -- within 21 calendar days from the start date of the event. A credit for the amount paid may be transferred to any future FDAnews event. Substitutions may be made at any time. No-shows will be charged the full amount. In the event that FDAnews cancels the event, FDAnews is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.
TEAM DISCOUNTS:
Significant tuition discounts are available for teams of three or more from the same company. You must register at the same time and provide a single payment to take advantage of the discount. Call 703-538-7600 for details.
ABOUT FDANEWS:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.
SOURCE:
FDAnews
http://www.CAPAworkshop.com
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02-01-2010 : & DERMATOLOGY TO BE HELD IN BARCELONA SPAIN
1st WORLD CONGRESS ON CONTROVERSIES IN PLASTIC SURGERY
& DERMATOLOGY TO BE HELD IN BARCELONA SPAIN
http://www.comtecmed.com/coplasdy/2010
A comprehensive Congress fully devoted to clinical debates & controversial issues in a wide spectrum in plastic surgery & dermatology
Nov 04-07 2010 -- Rey Juan Carlos Hotel, Barcelona Spain
Aug 04 2010 -- Abstract Submission Deadline
Sept 20 2010 -- Early Registration
Barcelona Spain -- Medical Industry E-Mail News™ -- Feb 01 2010 -- The 1st World Congress on Controversies in Plastic Surgery & Dermatology (CoPLASDy), will be held in Barcelona Spain in 2010, event hosts announced today.
The CoPLASDY congress is the first of its kind to convene plastic surgeons, dermatologists and nonsurgical aesthetic professionals, and continues a succession of congresses (in various disciplines of medicine) based on the concept of controversies and debates as the main platform.
Ample time will be provided for discussion. Attendees will have the advantage of conversing and debating unresolved issues with world authorities in their fields.
The Congress aims at reaching the ultimate state-of-the-art solutions, and providing clinicians with conclusive recommendations and reliable solutions, all based on current paramount significance.
Key Dates To Remember:
Nov 04-07 2010 -- Congress dates
Aug 04 2010 -- Abstract Submission Deadline
Sept 20 2010 -- Early Registration
Chairpersons:
Per Hedén
Arie Orenstein
Gerhard Sattler
Eyal Winkler
Background:
The beauty industry is a constantly growing and expanding business. Over the years the fields of plastic surgery and dermatology have undergone enormous expansion in clinical and basic data, as well as that of field-related technology.
The 1st World Congress on Controversies in Plastic Surgery and Dermatology (CoPLASDY) is the first of its kind to convene Plastic Surgeons and Dermatologists. In this sense CoPLASDY is unique in emphasizing the interface of surgery and non invasive procedures.
The intention of CoPLASDY is to function as an exclusive forum for world leading experts from these two disciplines to share and compare experiences and tackle controversial issues in order to outline appropriate treatments and extend their services.
Congress Goals:
Discuss etiology, management and new developments in a wide range of clinical dilemmas based on evidence and expert opinion
Reach the best clinical recommendation to current therapeutic dilemmas
Stimulate new research into currently unsolved controversies, promote education and public awareness
Key Points:
Abstract Submission:
http://www.comtecmed.com/coplasdy/2010/Submission.aspx
Accommodation:
http://www.comtecmed.com/coplasdy/2010/Accommodation.aspx
Registration:
http://www.comtecmed.com/coplasdy/2010/Registration.aspx
Preliminary Scientific Program:
http://www.comtecmed.com/coplasdy/2010/pp.aspx
Sponsorship & Exhibition:
http://www.comtecmed.com/coplasdy/2010/sponsorship.aspx
Sponsors:
http://www.comtecmed.com/coplasdy/2010/sponsors.aspx
General Information & Visas:
http://www.comtecmed.com/coplasdy/2010/general.aspx
Topics Include:
Prevention and treatment of Acne
Aging Face
Autologous Fat Harvesting & Grafting
Breast Augmentation Surgery with Silicone Implants
Business of Beauty
Cosmeceutical Products in The Aesthetic Clinic
Facial Rejuvenation
Facial Rejuvenation (With Fractionated Lasers)
Fat Grafting
Genital Surgery
Implants for Breast Reconstruction
Industry-Physician Relationships under Cross-Fire
Liposuction
Melanoma
Multidisciplinary Clinic
Non surgical Body Contouring
Adult regenerative Stem Cells: An Adjunct to Fat Grafting
Surgical vs Non surgical Facial Rejuvenation
Treatment of Cellulite
Skin rejuvenation: Lasers vs. Fillers vs. Chemical Peels
Upper Eyelid & Forehead Rejuvenation
The use of Botulinum Toxin-A
Controversies in hair transplantation
Continuing Medical Education:
Serono Symposia International Foundation will submit the main congress program for accreditation by the European Accreditation Council for Continuing Medical Education (EACCME). The program will be submitted for CME accreditation from the Italian Ministry of Health. CME accreditation is valid for the main congress program only and does not cover the company-sponsored symposia.
About Barcelona:
Barcelona is the most populous city of the Autonomous Community of Catalonia and the second largest city in Spain. Barcelona was founded as a Roman city and early in its history it became capital of the Counts of Barcelona. Today it is the capital of Catalonia. It remains today an important cultural center and a major tourist destination and has a rich cultural heritage. It is particularly renowned for its architectural works of Antoni Gaudí and Lluís Domènech I Montaner that have been designated UNESCO World Heritage Sites.
The Barri Gòtic is the center of the old city of Barcelona. Many of the buildings date from medieval times, some from as far back as the Roman settlement of Barcelona. Catalan modernism architecture, often known as Art Nouveau in the rest of Europe, developed between 1885 and 1950 and left an important legacy in Barcelona.
Barcelona contains 68 municipal parks, divided into 12 historic parks, 5 thematic (botanical) parks, 45 urban parks and 6 forest parts. These range from vest-pocket parks to large recreational areas. The urban parks alone cover 10% of the city. Barcelona has many museums, including the National Museum of Art of Catalonia, which possesses a well-known collection of Romanesque art. The Barcelona Museum of Contemporary Art focuses on post-1945 Catalan and Spanish Art.
The city has many venues for live music and theatre, including the world-renowned Gran Teatre del Liceu opera theater and the Palau de la Música Catalana concert hall. Barcelona is almost as lively at night as it is during the day and it has a unique, exciting atmosphere, which provides the visitor with a truly unforgettable experience.
Tourist Information for Spain:
http://www.barcelonaturisme.com
http://www.barcelona-tourist-guide.com
http://www.aboutbarcelona.com
SOURCE:
Comtecmed
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01-29-2010 : STERILIZATION STRATEGIES FOR PHARMACEUTICALS, BIOTECH, MEDICAL DEVICES & COMBINATIONAL PRODUCTS
STERILIZATION STRATEGIES FOR PHARMACEUTICALS, BIOTECH, MEDICAL DEVICES & COMBINATIONAL PRODUCTS
http://www.microrite.com/training.html
For Quality Assurance, Quality Control, Microbiologists, Validation, & Process Engineers
Application-Based Approach To Sterility Assurance Validation
March 04-05 2010 -- Biltmore Hotel & Suites; Santa Clara CA USA
San Jose CA USA -- Medical Industry E-Mail News™ -- Jan 29 2010 -- Microrite Inc., a leading provider of consulting services and training for pharma and medical device companies and related firms, announced today it is hosting a unique new training seminar on sterilization strategies.
Participants will benefit from speakers with more than 30 years of hands on validation of sterile medical devices. The intent of this seminar is an application-based approach to sterility assurance validation.
Who Should Attend:
Quality Assurance
Quality Control
Microbiologists
Validation
Process Engineers
When & Where:
Thur & Fri, March 04-05 2010
Biltmore Hotel & Suites, Santa Clara CA USA
TOPICS:
Understanding Gamma Irradiation, & E-Beam Sterilization
Overview of radiation & how gamma is used
Gamma materials selection & dosimetry
Introduction to ethylene oxide sterilization
Overview of electron beam processing
E-beam processing, penetration, dose mapping & product compatibility
Validation Gamma & ETO Sterilization Methods
Gamma
Overview of ISO 11137 – Sterility Assurance Validation (including any ISO updates)
Gamma Dose Setting Validation
Gamma Validation reporting
Dose auditing
EtO
Overview of ISO 11135 (including any ISO updates)
EtO Validation/Revalidation
EtO Validation Reporting
Also:
Reviewing Changes to Products or Processes
The FDA is Coming: Preparing for FDA and Notified Body Audits
Bonus Session:
Discussions and Q & A sessions will continue after 5 PM at Microrite’s Training Center. Do not miss the opportunity to have all of your important questions answered.
Bioburden Assessment:
Bioburden testing of medical devices is an essential part of routine control of manufacturing processes. Bioburden methods must be appropriate for the device to be assessed and must be validated. This seminar will review traditional bioburden and bioburden validation methods. Occasionally, bioburden is underestimated in spite of the validation efforts of the laboratory. This can cause significant problems in certain validation exercises, especially Method 1 gamma validations. A unique approach to bioburden assessment will be reviewed as part of this seminar.
Traditional bioburden & validation methods
Bioburden assessment – a unique MPN approach
This unique approach to bioburden assessment has been invaluable to certain gamma validation studies conducted by the presenter. Participants may find solutions to current bioburden assay problems in this presentation.
Current Best Practices for the Design & Validation of Sterilization Processes:
Strategies for implementation of sterilization processes and sterilization validation will be presented for pharmaceutical and biopharmaceutical process systems, support systems and equipment. Specific topics to be discussed include the following:
Microbiological & physical bases for current practices for sterilization processes & sterilization validation
Regulatory expectations for validation of sterilization processes
Effective master planning for validation of sterilization processes
Review of typical sterilization operations for process systems, support systems & equipment
Auditing strategies for effective management of excursions & deviations including establishment of root causes & proposal of corrective actions for OOS events
Risk based approaches to sterilization validation & ongoing monitoring of sterilization operation
To view the full brochure visit:
http://www.microrite.com/march_4_2010.pdf
To register visit:
http://www.microrite.com/training.html
SOURCE:
Microrite Inc
http://www.microrite.com
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01-28-2010 : SYNCARDIA'S TOTAL ARTIFICIAL HEART
GERMAN MAN BRIDGED-TO-TRANSPLANT AFTER 615 DAYS OF LIFE WITH
SYNCARDIA'S TOTAL ARTIFICIAL HEART
51-Year-Old Wanted to Keep His Total Artificial Heart but Feels "Newborn" After Donor Heart Transplant
http://www.syncardia.com
Tucson AZ USA -- Medical Industry E-Mail News™ -- Jan 28 2010 -- Bobby Dhawan, 51, is the owner of a successful taxi service in Germany. Normally, he does not allow bumper stickers to be placed on his cabs, but recently, he made a special exception for a sticker which reads, "Don't take your organs to heaven -- heaven knows we need them here."
Last August 2009, Dhawan received a donor heart transplant after living for 615 days with a SynCardia temporary CardioWest™ Total Artificial Heart. For nearly a year and a half prior to his transplant, Dhawan had enjoyed life at home with his family and gone back to work using the European portable driver to power his Total Artificial Heart.
"With the Total Artificial Heart, my health was so good and I felt so strong. I told myself, 'I don't want a human heart anymore, I want to keep my Total Artificial Heart,' " said Dhawan. "Today however, I think the donor heart transplant is the best thing I've ever done. I feel like a newborn person."
Dhawan was first diagnosed with an enlarged heart in 1996. Over the next 10 years, the cycle of getting sick, then getting better kept repeating. In 2007, Dhawan lost consciousness while driving and crashed into a wall at 80 km (50 miles) per hour. When he arrived at the hospital, doctors told him his heartbeat was irregular and extremely high, around 180-200 beats per minute.
Later, Dhawan was sent to the Heart & Diabetes Center NRW in Bad Oeynhausen, Germany. Doctors told him that if they didn't implant the Total Artificial Heart, he would die within the next 48 hours.
"The Total Artificial Heart not only saved my life, it saved my family's future," said Dhawan. "My taxi company has 17 cars and 35 drivers, and my wife wouldn't have been able to run the business alone. Today, my donor heart is working really well and I am back running my business. Other than having to take anti-rejection medication, I feel really great."
For nearly a year and a half prior to his heart transplant,
Bobby Dhawan was able to enjoy life at home and in
his community with his wife Heidi, using the European
portable driver to power his Total Artificial Heart.
About SynCardia Systems, Inc.
SynCardia Systems, Inc. is the Tucson-based manufacturer of the world's only FDA, Health Canada and CE approved Total Artificial Heart: the SynCardia temporary CardioWest™ Total Artificial Heart. There have been more than 800 implants of the Total Artificial Heart, accounting for more than 180 patient years of life on the device.
Originally used as a permanent replacement heart, the Total Artificial Heart is currently approved as a bridge to human heart transplant for people dying from end-stage biventricular failure. The Total Artificial Heart is the only device that provides immediate, safe blood flow of up to 9.5 L/min through both ventricles.
For additional information, please visit: http://www.syncardia.com
or follow SynCardia on Twitter – @SynCardia_News
SOURCE:
SynCardia Systems Inc
http://www.syncardia.com
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01-25-2010 : FDA Schedules Public Meeting on Pre-market Clearance Process for Medical Devices
FDA SCHEDULES PUBLIC MEETING ON PREMARKET
CLEARANCE PROCESS FOR MEDICAL DEVICES
-- Feb 18 2010 -- Hilton Washington DC, Gaithersburg MD
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm198479.htm
Irvine CA USA -- Medical Industry E-Mail News™ -- Jan 25 2010 -- The US Food & Drug Administration (FDA) has announced that it has scheduled a public meeting on Feb 18 2010, to discuss key challenges related to the premarket notification, or 510(k) process, used to review and clear certain medical devices marketed in the United States. The FDA receives more than 3,000 510(k) submissions each year.
The public notice for the meeting will appear in the Jan 27 2010 Federal Register.
In Sept 2009, the FDA said it had asked the Institute of Medicine (IOM) to conduct a comprehensive study of the process. The IOM study is not expected to conclude until March 2011.
In the meantime, the FDA has convened its own internal working group to evaluate and improve the quality and consistency of the FDA’s decision-making in the 510(k) process as well as its administration of the program. The February meeting will support the efforts of the FDA’s internal working group.
“It’s been more than 30 years since the establishment of the premarket notification process for medical devices,” said Jeffrey Shuren MD JD, Director of FDA’s Center for Devices & Radiological Health. “We are looking forward to hearing from the public on issues related to this program to help us improve it.”
At the meeting, FDA staff will present a brief overview of the challenges the agency has faced, organized in four categories: issues related to predicate devices, which are previously cleared devices that may support a manufacturer’s claim of substantial equivalence; issues related to new technologies and scientific evidence; issues related to practices the FDA has adopted in response to a high volume of submissions; and issues related to postmarket surveillance and new information about marketed devices.
Each of the four overview presentations will be followed by an open comment session. The meeting will close with a public roundtable discussion between FDA staff and selected participants representing a range of constituencies.
The Feb 18 meeting will be held 8 a.m.-5:30 p.m. at the Hilton Washington DC/North Gaithersburg, in Gaithersburg MD. Those interested in attending or participating in the meeting must register by 5 p.m. on Feb 12 2010. The agency is accepting written or electronic comments by March 5 2010.
The meeting will be Webcast live at: http://www.ConnectLive.com/events/fda021810
The 510(k) process was established under the Medical Device Amendments of 1976 to achieve two goals:
-- Make safe & effective devices available to consumers
-- Promote innovation in the medical device industry
During the past three decades, technology and the medical device industry have changed dramatically, making it an appropriate time for the FDA to review the adequacy of the premarket notification program in meeting these two goals. The FDA classifies medical devices into three categories according to their level of risk. Class III devices represent the highest level of risk and generally require premarket approval to support their safety and effectiveness before they may be marketed. Class III devices include heart valves and intraocular lenses.
Class I and Class II devices pose lower risks and include devices such as adhesive bandages and wheelchairs. Most Class II devices and some Class I devices can only be marketed after the FDA has found them to be substantially equivalent to legally marketed devices that do not require premarket approval, based on FDA’s review of submitted premarket notifications -- also called 510(k) applications.
Devices that are not found by the FDA to be substantially equivalent to a legally marketed device, such as those with a new intended use or that have different technological characteristics that raise different questions of safety and effectiveness, require premarket approval.
For more information
FDA’s Website on Premarket Notification (510k)
Institute of Medicine to Study Premarket Clearance Process for Medical Devices
FDA News Release: Sept 23 2009
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01-19-2010 : Successful Artificial Heart Pursued by Many, Achieved by One
SUCCESSFUL ARTIFICIAL HEART PURSUED BY MANY, ACHIEVED BY ONE
-- New SynCardia Website Features World's 1st & Only FDA, Health Canada & CE Approved Total Artificial Heart
http://www.syncardia.com
Tucson AZ USA -- Medical Industry E-Mail News™ -- Jan 19 2010 -- SynCardia Systems, Inc., manufacturer of the SynCardia temporary CardioWest™ Total Artificial Heart, has announced the launch of its new website (http://www.syncardia.com) to educate visitors that the artificial heart isn’t science fiction: it’s real, it works and it’s saving lives.
A quick search for “artificial heart” on Google News will produce a multitude of articles. Results include artificial hearts designed with aircraft technology, 13 chamber artificial hearts that mimic a cockroach heart and fully-implantable designs requiring pounds of equipment to be surgically implanted into the patient’s chest and abdomen.
Hundreds of artificial heart designs have been created, tested and ultimately shelved. Only one artificial heart has withstood the rigors of the human body and regulatory approval -- the SynCardia Total Artificial Heart. Today, it is the only FDA, Health Canada and CE Approved Total Artificial Heart in the world. There have been more than 800 implants accounting for more than 180 patient years.
Visitors to SynCardia’s new website (http://www.syncardia.com) will find more than double the content, including:
Clinical Experience: A presentation of data documenting the clinical success of the Total Artificial Heart as a bridge-to-transplant from some of the most reputable sources in medicine, including INTERMACS and the New England Journal of Medicine.
Patient Stories: Through their own words and personal photos, 10 patients share their experiences being bridged-to-transplant with the Total Artificial Heart.
Video Center: Featuring more than 20 videos, viewers can watch news stories, including a National Geographic multimedia feature, patient interviews, educational animations and more.
SynCardia has submitted an application to the FDA to conduct an IDE clinical study in the U.S. of a new discharge driver. This wearable driver is designed to power the Total Artificial Heart outside the hospital so stable patients can wait for their matching donor heart at home. SynCardia has also applied for CE Approval for use in Europe.
While there have been hundreds of artificial heart designs, only one artificial heart has withstood the rigors of the human body and regulatory approval -- the SynCardia Total Artificial Heart. Today, it is the world’s only FDA, Health Canada and CE Approved Total Artificial Heart.
About SynCardia Systems, Inc.
SynCardia Systems, Inc. is the Tucson-based manufacturer of the world’s only FDA, Health Canada and CE approved Total Artificial Heart: the SynCardia temporary CardioWest™ Total Artificial Heart. There have been more than 800 implants of the Total Artificial Heart, accounting for more than 180 patient years of life on the device.
Originally used as a permanent replacement heart, the Total Artificial Heart is currently approved as a bridge to transplant in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure. The Total Artificial Heart is the only device that provides immediate, safe blood flow of up to 9.5 L/min through both ventricles.”
SOURCE:
SynCardia Systems Inc
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01-14-2010 : HAITI:HOW TO CONTACT 70 US ORGANIZATIONS TO PROVIDE HELP
HAITI:HOW TO CONTACT 70 US ORGANIZATIONS TO PROVIDE HELP -- How Can I Help?
http://www.interaction.org/crisis-list/earthquake-haiti
Irvine CA USA -- Medical Industry E-Mail News™ -- Jan 14 2010 -- How Can I Help? For those interested in helping immediately, simply text "HAITI" to "90999" & a donation of $10 will be given automatically to the Red Cross to help with relief efforts, charged to your cell phone bill. Or you can donate to other relief organizations working in the affected region.
http://www.interaction.org/crisis-list/earthquake-haiti
Americans trying to locate family members in Haiti may contact the US State Dept: 888-407-4747.
===
Or contact any of the following organizations:
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AMERICAN RED CROSS HAITI RELIEF & DEVELOPMENT:
https://american.redcross.org/site/Donation2?idb=1188615655&df_id=4437&4437.donation=form1&JServSessionIdr004=mrs8resaf2.app195a
American Red Cross: 800-448-3543
http://www.redcrossblood.org/contact-us
===
US STATE DEPT:
http://www.state.gov/p/wha/ci/ha/earthquake/index.htm
US citizens are urged to contact the Embassy via email at ACSPaP@state.gov to request assistance. US citizens in Haiti can call the Embassy's Consular Task Force at 509-229-8942, 509-2229-8089, 509-2229-8322, or 509-2229-8672. The State Dept has also created a task force to monitor the emergency.
People in the US or Canada with information or inquiries about US citizens in Haiti may reach the Haiti Task Force: 888-407-4747. Outside of the US & Canada, call 202-501-4444.
The US Dept of State has received a high volume of calls concerning the welfare of US citizens in Haiti. To handle these requests most efficiently, the Dept has established an email address for people who are trying to contact their US citizen friends & relatives in Haiti. Please send your inquiries to: Haiti-earthquake@state.gov & include the following info:
* The full name, date of birth & passport info (if known) of the persons in Haiti you are trying to contact
* Their contact info in Haiti; phone numbers, email address, hotel name or address (if known)
* Your name & contact info, & your relationship to the person in Haiti (parent, spouse, friend etc.)
* Any special or emergency circumstances
A State Dept task force will work with our Embassy staff in Haiti to locate, and if needed, provide assistance. We will respond to each message as soon as possible. If you hear from the person you are concerned about, please be sure to send us an email providing the new information about their location or condition.
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CENTER FOR INTL DISASTER INFO:
Anyone wishing to donate or provide assistance in Haiti after the devastating earthquake is asked to contact the Center for Intl Disaster Information (CIDI), which has setup a dedicated page to coordinate Haiti support:
http://www.cidi.org/incident/haiti-10a
http://www.cidi.org
NGO Contact:
James Bishop
202-552-6524
jbishop@interaction.org
Elizabeth Bellardo
202-667-8227
ebellardo@interaction.org
Media Contact:
Nasserie Carew
202-552-6561
ncarew@interaction.org
Tawana Jacobs
202-552-6534
tjacobs@interaction.org
Donation Phone: 877-777-1420 x117
Donation Address:
247 W 37th St 10th Fl
New York NY 10018
===
ACTION AGAINST HUNGER - ACF INTL
Has mobilized an emergency response following the earthquake that devastated the city of Port-au-Prince yesterday. ACF teams on the ground have begun to carry out rapid evaluations across the city, while additional support, equipment, & materials -- including water treatment supplies, emergency vehicles, & communications equipment -- are en route from ACF’s bases in Gonaives. Also, a team has been mobilized to arrive with an initial planeload of emergency stocks from its staging grounds in Paris to supplement efforts on the ground.
http://actionagainsthunger.org
===
ACTIONAID INTL USA'S RESPONSE TO THE EARTHQUAKE IN HAITI
Donation Phone: 800-957-1768
Donation Address:
1420 K St NW Ste 900
Washington DC 20005
http://actionaidusa.org/what/emergencies/support_haitian_relief_efforts
ActionAid asks for donations for its relief efforts. ActionAid has been working in Haiti since 1996 & is deploying an emergency team to deliver clean water, shelter & goods like blankets & soap. Though communications were initially cut off by the quake, ActionAid’s Haiti Representative Jean-Claude Fignole sent out a desperate plea early this morning: "Send as much as you can, as quickly as you can." The scale of devastation completely overwhelms all available resources. Tens of thousands of people urgently need immediate help.
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ADVENTIST DEVELOPMENT & RELIEF AGENCY INTL'S RESPONSE TO THE EARTHQUAKE IN HAITI
Donation Phone: 800-424-2372
Donation Address:
12501 Old Columbia Pike
Silver Spring MD 20904
http://www.adra.org/haiti
ADRA has committed $1 mln to meet the needs of survivors. According to an initial assessment, the immediate needs include water purification supplies, food, temporary shelter materials, hygiene kits, & medical assistance. ADRA is also providing 4.2 mln water purification tablets, oral rehydration salts, water testing kits, mobile clinics, & other nonfood items for survivors. Additionally, ADRA is organizing intl rescue & medical teams to assist in the response.
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AFRICAN METHODIST EPISCOPAL CHURCH SERVICE & DEVELOPMENT AGENCY'S RESPONSE TO THE EARTHQUAKE IN HAITI
Donation Phone: 202-371-8722
Donation Address:
AME-SADA
1134 11th St NW
Washington DC 20001
http://www.interaction.org/organization/african-methodist-episcopal-church-service-and-development-agency
AME-SADA is currently assessing the situation in Haiti & will provide humanitarian relief & care onsite through our system of local clinics & micro credit operations.
===
AIR SERV INTL'S RESPONSE TO THE EARTHQUAKE IN HAITI
Donation Phone: 540-428-2323
Donation Address:
Air Serv Intl
410 Rosedale Ct Ste 190
Warrenton VA 20186
http://www.airserv.org
ASI is coordinating & assisting with small aircraft & crews for immediate deployment in support of the Haiti earthquake response. Charter flights to/from Haiti for people & supplies, dedicated aircraft for short term or open-ended in-country use.
===
AMERICAN FRIENDS SERVICE COMMITTEE'S RESPONSE TO THE EARTHQUAKE IN HAITI
Donation Phone: 888-588-2372
Donation Address:
American Friends Service Committee
1501 Cherry St
Philadelphia PA 19102
http://afsc.org
Accepting financial aid only at this time. Funds will go to immediate material needs & to help Haitians themselves rebuild their communities.
===
AMERICAN JEWISH JOINT DISTRIBUTION COMMITTEE'S RESPONSE TO THE EARTHQUAKE IN HAITI
Donation Phone: 212-687-6200
Donation Address:
711 3rd Ave 10th Fl
New York NY 10017
https://www.jdc.org/donation/donate.aspx
JDC is currently accepting donations to support its relief efforts following the catastrophic earthquake that struck Haiti. Now & in the months to come, JDC will provide both immediate relief as well as long-term assistance to help the Haitian people rebuild their lives. JDC is conducting a full & rapid assessment of the situation on the ground, & reaching out to its network of partners to determine critical next steps based on immediate needs. JDC, as Chair of the Jewish Coalition for Disaster Relief, is coordinating the Haiti related efforts of its 45 member organizations.
===
AMERICAN JEWISH WORLD SERVICE'S RESPONSE TO EARTHQUAKE IN HAITI
Donation Phone: 212-792-2900
Donation Address:
45 W 36th St 10th Fl
New York NY 10018
http://www.ajws.org/haitiearthquake
AJWS is collecting donations in response to the massive earthquake in Haiti. Donations to AJWS's Haiti Earthquake Relief Fund will enable AJWS's network of grantees in Haiti to meet the urgent needs of the population based on real-time, on-the-ground assessments.
===
AMERICAN REFUGEE COMMITTEE INTL'S RESPONSE TO THE EARTHQUAKE IN HAITI
Donation Phone: 800-875-7060
Donation Address:
430 Oak Grove St Ste 204
Minneapolis MN 55403
http://arcrelief.org
ARC is deploying an emergency response team that will arrive in Port-au-Prince by Thurs morning. Sr Dir of Program Quality Monte Achenbach, who previously lived & worked in Haiti, will lead the team’s efforts. Top priorities include assessing the situation on the ground & planning a coordinated response in conjunction with other relief organizations. ARC has funds in hand to support immediate food/non-food item distribution; water, sanitation, & hygiene needs; & primary health care. ARC will stay in Haiti through the recovery period, focusing on shelter, reconstruction, & livelihoods.
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AMERICARES' RESPONSE TO EARTHQUAKE IN HAITI
Donation Phone: 800-486-4357
Donation Address:
AmeriCares
88 Hamilton Ave
Stamford CT 06902
http://www.AmeriCares.org
AmeriCares is mobilizing emergency disaster relief & medical aid in response to the earthquake that struck Haiti. AmeriCares has pledged $5 mln to the people of Haiti & is working closely with in-country partners to target the most devastated regions. AmeriCares is preparing resources from its Connecticut based warehouse for delivery to the people of Haiti immediately as the country becomes accessible.
===
ANANDA MARGA UNIVERSAL RELIEF TEAM (AMURT)'S RESPONSE TO THE EARTHQUAKE IN HAITI
Donation Phone: 301-738-7122
Donation Address:
2502 Lindley Terrace
Rockville MD 20850
http://amurt.us
AMURT currently has a team on the ground in Port au Prince setting up medical & food relief. AMURT volunteers have a great deal of experience working in disaster relief in Haiti, & will be working there for the foreseeable future.
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B'NAI B'RITH INTL'S RESPONSE TO THE EARTHQUAKE IN HAITI
Donation Phone: 800-573-9057
Donation Address:
Headquarters
2020 K St NW 7th Fl
Washington DC 20006
http://www.bnaibrith.org
B'nai B'rith is funding emergency relief teams from Israel's Humanitarian Organizaitons that are coordinated by IsraAid. B'nai B'rith has provided disaster assitance for manmade & natural disasters since 1865.
===
BAPTIST WORLD ALLIANCE / BAPTIST WORLD AID'S RESPONSE TO EARTHQUAKE IN HAITI
Donation Phone: 703-790-8980
Donation Address:
Baptist World Alliance/Baptist World Aid
405 N Washington St
Falls Church VA 22046
http://bwanet.org/bwaid
BWA is working through its member bodies in Haiti & with our intl rescue teams. Haitian Baptists are in country, know the situation, have a local network of churches & can respond. Rescue teams are enroute to Haiti on Wednesday morning & will coordinate with relief efforts on the ground.
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BROTHER'S BROTHER FOUNDATION'S RESPONSE TO EARTHQUAKE IN HAITI
Donation Phone: 412-321-3160
Donation Address:
1200 Galveston Ave
Pittsburgh, PA, 15233
http://brothersbrother.org
BBF is working with partner organization Food for the Poor to send requested medical relief supplies to those in need in Haiti. BBF has a 40-year history of work in Haiti & sent requested pharmaceuticals, surgical instruments & other supplies as recently as Dec 30 2009.
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CARE'S RESPONSE TO THE EARTHQUAKE IN HAITI
Donation Phone: 800-521-CARE
Donation Address:
151 Ellis St
Atlanta GA 30303
http://www.care.org/donatehaiti
CARE has over 100 staff members in Haiti & is deploying additional emergency personnel. Contributions will support immediate emergency operations including getting desperately needed food & water to the Haitians. CARE has extensive experience responding to disasters of this magnitude. Many of CARE’s staff in Haiti include emergency personnel who were part of the response to the devastating Hurricane Hanna in 2008. CARE began working in Haiti in 1954 to provide relief assistance after Hurricane Hazel. Today CARE's work in Haiti includes projects in HIV/AIDS, reproductive health, maternal & child health, education, food security, & water & sanitation.
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CATHOLIC RELIEF SERVICES'S RESPONSE TO EARTHQUAKE IN HAITI
Donation Phone: 877-HELP-CRS
Donation Address:
PO Box 17090
Baltimore MD 21203
http://crs.org
CRS has made an initial commitment of $5 mln for immediate use in the relief effort. CRS is geared up for a major emergency response to this severe disaster. CRS is mobilizing food & gearing up our emergency capacity, & deploying prepositioned emergency shelter & hygiene kits in Haiti, as well as bringing supplies in from the neighboring Dominican Republic.
===
CHF INTL'S RESPONSE TO EARTHQUAKE IN HAITI
Donation Phone: 301-587-4700
Donation Address:
CHF Intl
8601 Georgia Ave Ste 800
Silver Spring MD 20910
http://www.chfinternational.org/node/33879
CHF will distribute food aid, water & shelter in the immediate aftermath, then will focus on the needs of the people as they transition from basic survival to recovery. This includes some of CHF’s areas of greatest expertise, such as building transitional shelters; temporary homes that meet intl standards where a family can live during the recovery period; helping to generate livelihoods, by employing people in the clean up of their community; & aiding reconstruction efforts by creating earthquake resistant buildings.
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CHRISTIAN REFORMED WORLD RELIEF COMMITTEE'S RESPONSE TO THE EARTHQUAKE IN HAITI
Donation Phone: 800-55-CRWRC
Donation Address:
2850 Kalamazoo Ave SE
Grand Rapids MI 49560-0600
http://crwrc.org
CRWRC has staff, partners, & community networks on the ground in Port au Prince, who are coordinating an immediate response that will include items such as food, water, & shelter. N. American staff & volunteers will arrive in Haiti on Friday to assess needs beyond the immediate, including near-term & intermediate response phases.
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CHURCH WORLD SERVICE'S RESPONSE TO THE EARTHQUAKE IN HAITI
Donation Phone: 800-297-1516
Donation Address:
28606 Phillips St
PO Box 968
Elkhart IN 46515
http://www.churchworldservice.org
As part of initial efforts, CWS is sending funds to local partners in Haiti as it continues to assess the situation, & is ready to provide CWS Kits & CWS Blankets to those in need. CWS will be working with fellow members of the ACT Alliance & local partners in Haiti. CWS-supported efforts will include the construction of temporary water systems, providing water purification materials, tents & food packages. Additional efforts will be announced once assessments are completed.
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CONCERN WORLDWIDE US'S RESPONSE TO EARTHQUAKE IN HAITI
Donation Phone: 800-59-CONCERN
Donation Address:
104 East 40th St Rm 903
New York NY 10016
http://concernusa.org
Concern calls on the public for urgent support to allow the agency to provide food, water, shelter & medicine as the immediate priority for those that have survived the catastrophe.
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DIRECT RELIEF INTL'S RESPONSE TO THE EARTHQUAKE IN HAITI
Donation Phone: 805-964-4767
Donation Address:
27 S La Patera Ln
Santa Barbara CA 93117
http://DirectRelief.org
The organization announced it will commit up to $1 mln in aid for the response & is coordinating with its other in-country partners & colleague organizations. Emergency aid is being offered to all our partners in Haiti to support their response to the quake. Two shipping containers of medical material aid were scheduled to arrive yesterday in Port-au-Prince. The 40-ft & 20-ft containers, containing over $420,000 of essential medicines, supplies, & nutritionals, were destined for St. Damien Children’s Hospital. The hospital is one of 3 local facilities in Haiti with which DR has partnered in its Emergency Pre-Positioning Program.
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EPISCOPAL RELIEF & DEVELOPMENT'S RESPONSE TO EARTHQUAKE IN HAITI
Donation Phone: 800-334-7626 ext 5129
Donation Address:
815 2nd Ave
New York NY 10017
http://er-d.org
ERD has reached out to its Haitian partners in an effort to determine the extent of the damage & coordinate a swift response. The agency has disbursed emergency relief funds to the Diocese of Haiti to help them meet immediate needs such as providing food, shelter & water, & stands ready to support their ongoing recovery as they rebuild their ministries.
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FLORESTA USA INC.'S RESPONSE TO THE EARTHQUAKE IN HAITI
Donation Phone: 800-633-5319
Donation Address:
4903 Morena Blvd Ste 1215
San Diego CA 92117
http://www.plantwithpurpose.org
Floresta-Plant With Purpose works to bring long-term healing & prosperity to rural communities by facilitating economic & agricultural development. Since 1984 we have planted 4.5 mln trees, made thousands of small business loans & empowered many thousands of rural poor to work their way out of poverty. We have worked in Haiti since 1997 & currently have 40 Haitian staff serving 37 communities. Our staff will be working to aid Haitian communities in their long-term recovery.
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FOOD FOR THE HUNGRY'S RESPONSE TO EARTHQUAKE IN HAITI
Donation Phone: 800-248-6437
Donation Address:
Food for the Hungry
1224 E Washington St
Phoenix AZ 85034
http://fh.org
FH has staff on the ground who are assessing the needs, & FH's Dir of Emergency Response is on her way to Haiti to create a FH-wide plan to respond. FH's operational focus in Haiti is HIV/AIDS & Child/Maternal health, & we will be looking to respond in these areas as well as other areas of need.
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FRIENDS OF ACTED'S RESPONSE TO THE EARTHQUAKE IN HAITI
Donation Phone: 202-341-6365
Donation Address:
Friends of ACTED
1400 16th St NW Ste 210
Washington DC 20036
http://www.acted.org
ACTED has a long term presence in Haiti, with a Capital office in Port au Prince & 4 field offices, a team of 6 intl staff & 100 national staff implementing emergency & development activities throughout the country. For the current earthquake crisis, the organization is launching a primary emergency response targeting most affected areas of Port au Prince & neighboring areas, focused on water & sanitation, food assistance, emergency shelter, health & protection of most vulnerable community members, women & children. ACTED has already secured a donation of 1,000 shelter kits from Shelterbox, which will be distributed in the soonest delays.
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FRIENDS OF THE WORLD FOOD PROGRAM'S RESPONSE TO EARTHQUAKE IN HAITI
Donation Phone: 866-929-1694
Donation Address:
Friends of the World Food Program
1819 L St NW Ste 900
Washington DC 20036
http://www.friendsofwfp.org/donate
The United Nations WFP is mobilizing all available resources to bring food assistance to thousands of people affected by the earthquake. As well as causing widespread death & destruction, the quake left thousands of people hungry. WFP is well positioned to respond as it already has stocks of food pre-positioned. In the initial phase, WFP will distribute high energy biscuits, which require no cooking. We will airlift 86 metric tons of food from our emergency hub in El Salvador. This will feed 30,000 people for up to 7 days. WFP emergency staff will also be deployed.
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GIVING CHILDREN HOPE'S RESPONSE TO EARTHQUAKE IN HAITI
Donation Phone: 714-523-4454
Donation Address:
8332 Commonwealth Ave
Buena Park CA 90621
http://gchope.org
GCH is talking with partners in Haiti, determining the greatest needs of the earthquake victims. GCH has recently sent medical supplies to aid orphans & to replenish a local hospital in that country.
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HABITAT FOR HUMANITY INTL'S RESPONSE TO THE EARTHQUAKE IN HAITI
Donation Phone: 800-422-4828
Donation Address:
121 Habitat St
Americus GA 31709-3498
http://www.habitat.org
Habitat has been at work in Haiti for 26 years & will use its local expertise & mobilize resources as part of the rebuilding efforts. Habitat has provided more than 2,000 families with housing solutions through a variety of initiatives including new home construction, progressive building, home repairs & improvements. It also builds capacity in construction skills, disaster mitigation & financial literacy, & works in coordination with community & government agencies.
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HANDICAP INTL'S RESPONSE TO THE EARTHQUAKE IN HAITI
Donation Phone: 301-891-2138
Donation Address:
6930 Carroll Ave Ste 240
Takoma Park MD 20912
http://handicap-international.us
Already present in Haiti, Handicap Intl reacted rapidly to the earthquake, which hit the country Tues night. The association released $217,657 (€150,000) in funding Wed & will provide support for the team. Handicap Intl will provide care to those injured by the earthquake, including support to hospitals, & emergency shelter, emergency basic needs & food distribution for at least 5,000 people. An emergency response team comprised of at least 10 individuals, both physical therapists & logisticians, will depart for Haiti imminently & will coordinate the distribution of approx 1 ton of equipment & emergency supplies.
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HANDS ON DISASTER RESPONSE'S RESPONSE TO THE EARTHQUAKE IN HAITI
Donation Phone: 919-830-3573
Donation Address:
PO Box 546
Carlisle MA 01741-0546
http://www.HODR.org/HaitiEarthquake
HOD is returning to Haiti after a 2008-09 hurricane response project, to determine how & where HOD's main resource of volunteers would be most effective in the response & recovery efforts.
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HEART TO HEART INTL'S RESPONSE TO EARTHQUAKE IN HAITI
Donation Phone: 866-341-4483
Donation Address:
401 S Clairborne Ste 302
Olathe KS 66062
http://hearttoheart.org
HHI is sending medical aid & medical volunteers in support of local relief efforts surrounding the earthquake.
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HELPAGE USA'S RESPONSE TO THE EARTHQUAKE IN HAITI
Donation Phone: 202-714-1119
Donation Address:
HelpAge USA
4750 41st St NW Ste 410
Washington DC 20016
http://www.helpageusa.org
HelpAge USA has launched a Haiti Emergency Response Fund to assist the 800,000 older people who are the most at-risk during a disaster of this magnitude. At this point, operations are focused primarily on search & rescue, followed by the provision of food, water, shelter, & medical attention. Older people in Haiti face specific challenges in this situation, including those arising from a lack of mobility, special medical concerns, & marginalization & exclusion from resources. HelpAge Intl is the only relief organization focusing specifically on the needs & contributions of older people in the wake of the earthquake in Haiti.
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HOLT INTL CHILDREN'S SERVICES'S RESPONSE TO THE EARTHQUAKE IN HAITI
Donation Phone: 541-687-2202
Donation Address:
Holt Intl Children's Services
1195 City View PO Box 2880
Eugene OR 97402
http://www.holtinternational.org
Holt Intl has a child care center 40 miles north of Port-au-Prince as well as a family preservation program for more than 100 families. Holt staff in Haiti are assessing the needs of children & families in our programs & expecting to provide additional support to additional families who have been affected by the tragedy in Haiti. Funds are needed for additional supplies & resources to maintain the child care center & the anticipated influx of children & families.
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HUMANE SOCIETY INTL'S RESPONSE TO THE EARTHQUAKE IN HAITI
Donation Phone: 202-452-1100
Donation Address:
Humane Society Intl
2100 L St NW
Washington DC 20037
http://www.hsi.org
While the immediate & critical needs of the people of Haiti are met following the catastrophic earthquake, Humane Society Intl has offered to send veterinary experts to vaccinate, treat injuries & rescue animals affected by the disaster. Animals are an intrinsic part of the lives of millions of Haitians -- both those animals on whom they depend for livelihood & those who provide comfort & emotional support. Dead & displaced animals will pose a threat to the people of Haiti & could threaten the long-term survival of its agricultural community. Addressing this need is a critical component of the disaster response.
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INTL MEDICAL CORPS' RESPONSE TO THE EARTHQUAKE IN HAITI
Donation Phone: 800-481-4462
Donation Address:
1919 Santa Monica Blvd Ste 400
Santa Monica CA 90404
https://www.imcworldwide.org/SSLPage.aspx?pid=878
IMCs’ Emergency Response Team is in Haiti, focusing on providing lifesaving medical care & relief to survivors of this devastating earthquake. The response draws on 25 years of experience in emergency settings, including last Sept’s earthquake in Sumatra, Indonesia, & the massive 2005 earthquake in Pakistan.
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INTL ORTHODOX CHRISTIAN CHARITIES' RESPONSE TO EARTHQUAKE IN HAITI
Donation Phone: 877-803-4622
Donation Address:
IOCC
110 West Rd Ste 360
Baltimore MD 21204
http://www.iocc.org
IOCC has mobilized its disaster response team & is coordinating with our Orthodox & ecumenical partners to monitor & respond to the emerging needs in Haiti. “This earthquake has brought more suffering to a nation that was already one of the hemisphere’s most impoverished,” said IOCC Exec Dir & CEO Constantine M. Triantafilou. “IOCC will be working with our fellow ACT Alliance members who are already in place to provide emergency relief to those affected by the earthquake.”
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INTL RELIEF & DEVELOPMENT'S RESPONSE TO EARTHQUAKE IN HAITI
Donation Phone: 703-248-0161
Donation Address:
1621 N Kent St 4th Fl
Arlington VA 22209
http://www.ird-dc.org
IRD has mobilized an emergency response team to Haiti in response to the earthquake in Port-au-Prince & surrounding areas. IRD will focus on the provision of emergency commodities, such as water, sanitation kits, hygiene kits & shelter materials.
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INTL RELIEF TEAMS' RESPONSE TO EARTHQUAKE IN HAITI
Donation Phone: 619-284-7979
Donation Address:
Intl Relief Teams
4560 Alvarado Canyon Rd Ste 2G
San Diego CA 92120
http://irteams.org
IRT is partnering with other intl relief agencies to supply substantial aid to the earthquake victims. One of IRT's partners is en route to Haiti with a team to provide onsite assessment. IRT anticipates sending medicines, food, shelter, & other relief supplies, & medical personnel, depending upon specific need, to the devastated region.
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INTL RESCUE COMMITTEE'S RESPONSE TO THE EARTHQUAKE IN HAITI
Donation Phone: 877-REFUGEE
Donation Address:
Intl Rescue Committee
122 E 42nd St
New York NY 10168
http://theIRC.org
IRC is deploying its emergency response team to Haiti to launch an immediate response to help earthquake survivors. Our immediate focus will be getting medical care, clean water, & emergency sanitation to survivors & supporting overwhelmed local partners on the ground.
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ISLAMIC RELIEF USA'S RESPONSE TO THE EARTHQUAKE IN HAITI
Donation Phone: 888-479-4968
Donation Address:
3655 Wheeler Ave
Alexandria VA 22304
http://irw.org
Islamic Relief USA has launched a $1 mln appeal for the earthquake victims, & is coordinating a massive shipment of much-needed aid to Haiti.
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JESUIT REFUGEE SERVICE / USA'S RESPONSE TO THE EARTHQUAKE IN HAITI
Donation Phone: 202-629-5948
Donation Address:
Jesuit Refugee Service/USA
1016 16th St NW Ste 500
Washington DC 20036
http://jrsusa.org
JRS is mounting an emergency relief effort to provide lifesaving aid, including food & other urgently needed assistance, to the Haitian people. Aid will be provided in partnership with the JRS Latin America & Caribbean regional office, & distributed through the JRS cross border relief programs in the Dominican Republic, & to Jesuit parishes & other Jesuit programs in Haiti. For many years Jesuit Refugee Service has maintained a grassroots presence in Haiti & has provided humanitarian assistance to displaced Haitians both in Haiti & in the Dominican Republic, responding to needs arising from political crises & repeated natural disasters.
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LIFE FOR RELIEF & DEVELOPMENT'S RESPONSE TO THE EARTHQUAKE IN HAITI
Donation Phone: 248-424-7493
Donation Address:
Life for Relief & Development
17300 W 10 Mile Rd
Southfield MI 48128
http://lifeusa.org
LRD started mobilizing to send aid to Haiti immediately after the earthquake occurred. Life plans to provide food, water, temporary shelter, hygiene kits & medical aid to aid victims in the earthquake affected areas.
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LUTHERAN WORLD RELIEF'S RESPONSE TO EARTHQUAKE IN HAITI
Donation Phone: 800-597-5972
Donation Address:
700 Light St
Baltimore MD 21230
http://www.lwr.org/giving
LWR has partners on the ground in Haiti & is responding immediately.
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MAP INTL'S RESPONSE TO THE EARTHQUAKE IN HAITI
Donation Phone: 800-225-8550
Donation Address:
2200 Glynco Pkwy
Brunswick GA 31525
http://www.map.org
MAP Intl has 40+ yrs of experience providing essential medicine & medical supplies to Haiti. Over $2 mln-worth is already on its way to Haiti, as is MAP’s Dir of Intl Medical Resources. Through its extensive network of partnerships on the ground & relationships with major pharmaceutical companies, MAP plans to ship 5 sea containers w/20 pallets of supplies over the next 2 weeks & another 10 over the next 6 months. MAP seeks donations in the form of cash & medical GIK.
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MEDICAL EMERGENCY RELIEF INTL, USA (MERLIN)'S RESPONSE TO THE EARTHQUAKE IN HAITI
Donation Phone: 202-449-6398
Donation Address:
1600 K St NW Ste 450
Washington DC 20006
http://www.merlin-usa.org
Merlin is responding to the earthquake that struck Haiti. Merlin’s emergency response team will immediately begin working with Haitians & other intl agencies to meet the most urgent needs: water, sanitation, shelter, disease prevention & restoration of basic health services. The main elements of Merlin’s Haiti emergency response are expected to be: distribution of aid materials & equipment, support to local health staff, & training community members to help protect public health. Merlin is calling on the public to provide support in our relief efforts.
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MEDICAL TEAMS INTL'S RESPONSE TO THE EARTHQUAKE IN HAITI
Donation Phone: 800-959-4325
Donation Address:
14150 SW Milton Ct
Tigard OR 97224
http://www.medicalteams.org/haiti
MTI is mobilizing 2 volunteer medical teams to Haiti immediately. We also are in touch with partners on the field & gathering medical supplies & financial support to help respond where needed most.
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MERCY CORPS' RESPONSE TO THE EARTHQUAKE IN HAITI
Donation Phone: 888-256-1900
Donation Address:
45 Ankeny St
Portland OR 97201
http://mercycorps.org
Mercy is sending a team of emergency responders to Haiti. The team will assess damage, & seek to fulfill immediate needs of quake survivors. The earthquake exacerbates an already dire humanitarian situation in Haiti, the poorest country in the W Hemisphere. Plagued by hunger & political instability, the quake is likely to dramatically increase the needs of many impoverished Haitian families. Mercy Corps has a long history of helping earthquake survivors. The agency aided families after earthquakes in Peru in 2007, China & Pakistan in 2008, & Indonesia last year.
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OPERATION BLESSING'S RESPONSE TO THE EARTHQUAKE IN HAITI
Donation Phone: 800-730-2537
Donation Address:
977 Centerville Turnpike
Virginia Beach VA 23463
http://www.operationblessing.org
Operation Blessing’s Haiti National Director, Eric Lotz, is in Haiti, making first responder assessments. Disaster relief teams are mobilizing to bring emergency relief to victims. OBI is coordinating with Dr. Paul Farmer’s Haitian NGO "Partners in Health" (PIH), to provide maximum strategic relief. PIH has hundreds of employees & medical staff already on the ground & we are working to leverage our resources to help countless thousands of victims.
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OPERATION USA'S RESPONSE TO EARTHQUAKE IN HAITI
Donation Phone: 800-678-7255
Donation Address:
Operation USA
3617 Hayden Ave Ste A
Culver City CA 90232
http://opusa.org
Working with on ground partner agencies to provide medical care, access to safe water, shelter & energy supplies.
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OXFAM AMERICA'S RESPONSE TO EARTHQUAKE IN HAITI
Donation Phone: 800-776-9326 (800-77-OXFAM)
Donation Address:
226 Causeway St 5th Fl
Boston MA 02114
http://oxfamamerica.org
Oxfam has long experience in Haiti, & we're rushing in teams from around the region to respond to the situation where our assistance is most needed. Our response will include providing clean water, shelter, sanitation & helping people recover. Your donation will go immediately to the most critical needs in Haiti, & we will ensure that every penny is used wisely.
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PHYSICIANS FOR PEACE'S RESPONSE TO EARTHQUAKE IN HAITI
Donation Phone: 757-625-7569
Donation Address:
Physicians for Peace
229 W Bute St Ste 200
Norfolk VA 23510
http://physiciansforpeace.org
Through Physicians for Peace’s partner network of Healing Hands for Haiti & St. Vincent’s School for Handicapped Children (and others), both in the capital city of Port au Prince, donations will go directly to provide immediate trauma relief as well as longer term assistance for amputees. Healing Hands for Haiti has been providing orthotic & prosthetic services to the people of Haiti since 1998 using both US & Haiti specialists. St. Vincent’s School for Handicapped Children is a multi-service facility that provides preschool through high school education, vocational training, physical therapy & medical care.
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PLAN USA'S RESPONSE TO THE EARTHQUAKE IN HAITI
Donation Phone: 800-556-7918
Donation Address:
Plan USA
155 Plan Way
Warwick RI 02886
https://www.planusa.org
Plan has released $100,000 of emergency funds & is on the ground in Haiti to help deal with the immediate aftermath of the country’s worst earthquake.
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PROJECT C.U.R.E.'S RESPONSE TO THE EARTHQUAKE IN HAITI
Donation Phone: 303-792-0729
Donation Address:
Project C.U.R.E. Intl Headquarters
10377 E Geddes Ave
Centennial CO 80112
http://www.projectcure.org
Project C.U.R.E. provides donated medical supplies, equipment, & services to doctors, nurses, health care clinics, & hospitals in 123 developing countries. We always conduct an onsite needs assessment to determine the unique medical relief needs of each medical facility.
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PROJECT CONCERN INTL'S RESPONSE TO THE EARTHQUAKE IN HAITI
Donation Phone: 858-279-9690
Donation Address:
5151 Murphy Canyon Rd Ste 320
San Diego CA 92123
http://www.projectconcern.org
PCI is mobilizing an emergency response to deliver medicines, hygiene kits & other lifesaving supplies to those affected by the earthquake. PCI will work in close coordination with key partners on the ground to reach those most affected by the disaster. PCI is deploying staff to Port-au-Prince immediately to assess the situation on the ground.
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RELIEF INTL'S RESPONSE TO THE EARTHQUAKE IN HAITI
Donation Phone: 323-932-7888
Donation Address:
5455 Wilshire Blvd Ste 1280
Los Angeles CA 90036
http://ri.org
RI is currently carrying out a rapid damage & needs assessment in response to the Haiti earthquake. In the coming days, RI will provide immediate emergency response in the form of food & nonfood items, & sector specific responses in health, education, & temporary shelter. Longer-term assistance plans such as livelihoods, cash for work, & local capacity development for disaster risk reduction are simultaneously being developed.
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SAVE THE CHILDREN'S RESPONSE TO THE EARTHQUAKE IN HAITI
Donation Phone: 800-728-3843
Donation Address:
54 Wilton Rd
Westport CT 06880
http://savethechildren.org
Save has identified these areas of immediate priority: addressing shelter, health, water, sanitation, & child protection needs and, as conditions allow, the restoration of education for children.
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STOP HUNGER NOW'S RESPONSE TO THE EARTHQUAKE IN HAITI
Donation Phone: 919-839-0689
Donation Address:
2501 Clark Ave Ste 301
Raleigh NC 27607
http://stophungernow.org
SHN will be coordinating relief efforts to our partners in Haiti by organizing shipments of meals & financial support. We are in contact with our long time partners at Haiti Outreach Ministries & will continue to support their feeding programs & rebuilding efforts.
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UNITARIAN UNIVERSALIST SERVICE COMMITTEE'S RESPONSE TO THE EARTHQUAKE IN HAITI
Donation Phone: 800-766-5236
Donation Address:
UUSC/UUA Haiti Earthquake Relief Fund
PO Box 844001
Boston MA 02284-4001
http://www.uusc.org/haitiearthquake
UUSC responds strategically to disaster situations where human rights are threatened, focusing on the rights of marginalized & oppressed people. We work with the understanding that disasters, whether natural or man-made, tend to disproportionately harm those who are already marginalized in society or are neglected by traditional relief strategies. In response to the earthquake in Haiti, UUSC will identify & channel relief funds to grassroots & colleague organizations that are best able to provide immediate aid to survivors, as well as to meet longer-term needs of recovery.
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UNITED METHODIST COMMITTEE ON RELIEF'S RESPONSE TO THE EARTHQUAKE IN HAITI
Donation Phone: 800-554-8583
Donation Address:
United Methodist Committee on Relief
475 Riverside Dr Rm 330
New York NY 10115
http://umcor.org
UMCOR is working with partners, Action by Churches Together, Church World Service, Global Medic & the Methodist Church, UMCOR is channeling its resources to respond effectively to the people most in need.
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UNITED WAY INTL'S RESPONSE TO THE EARTHQUAKE IN HAITI
Donation Phone: 703-836-7112
Donation Address:
United Way Worldwide Disaster Fund
701 North Fairfax St
Alexandria VA 22314
http://www.liveunited.org
You can help people affected by donating to the United Way Worldwide Disaster Fund. Gifts to the Fund support long-term recovery efforts to rebuild lives & infrastructure devastated by disaster & to address educational, financial & health-related challenges. United Way Worldwide members in the Caribbean region have mobilized their staff, volunteer leaders & resources in response.
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US FUND FOR UNICEF'S RESPONSE TO EARTHQUAKE IN HAITI
Donation Phone: 800-4UNICEF
Donation Address:
US Fund for UNICEF
125 Maiden Ln 11th Fl
New York NY 10038
http://www.unicefusa.org
Despite heavy damages to its own offices in Port-au-Prince, UNICEF is ready to provide immediate support to the estimated 3 mln victims of the unfolding humanitarian crisis following the earthquake that hit Haiti yesterday. UNICEF officials estimate that half of those affected by the quake are children. In coordination with other UN agencies present on the ground, UNICEF will provide supplies to allow access to adequate sanitation, safe water & basic health care.
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WORLD CONCERN'S RESPONSE TO THE EARTHQUAKE IN HAITI
Donation Phone: 866-530-5433
Donation Address:
19303 Fremont Ave N
PO Box 33000, MS #44
Seattle WA 98133
http://worldconcern.org
During this initial response, we are providing blankets, emergency shelters & supplies of clean water. There is a very high likelihood that existing water systems will be combined with sewage.
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WORLD HOPE INTL RESPONSE TO EARTHQUAKE IN HAITI
Donation Phone: 703-923-9414
Donation Address:
World Hope Intl
625 Slaters Ln Ste 200
Alexandria VA 22314
http://www.worldhope.org
WHI is mobilizing its 60-strong Haitian staff & community volunteers to respond with food, safe water, cooking fuel & other basic supplies as available. As the work of first responders ebb, WHI will expand its response by mobilizing US volunteers to assist the Haitian staff & communities in clean-up & rebuilding. WHI responds to natural disasters where it has the national staff & capacity (as it does in Haiti) to do so effectively. WHI first began in Haiti in 1996 & presently implements a large-scale HIV/AIDS program funded by USAID.
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WORLD NEIGHBORS' RESPONSE TO THE EARTHQUAKE IN HAITI
Donation Phone: 405-752-9700
Donation Address:
World Neighbors
4127 NW 122nd St
Oklahoma City OK 73120
http://wn.org
World Neighbors has been working in Haiti since 1995 to eliminate hunger, poverty & disease using people-centered approaches that address the inter-connected problems of declining food production, malnutrition, ill health & environmental degradation in underserved areas of Haiti. The organization currently works in 8 program areas, north of Port-au-Prince.
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WORLD RELIEF'S RESPONSE TO THE EARTHQUAKE IN HAITI
Donation Phone: 800-535-5433
Donation Address:
World Relief
7 E Baltimore St
Baltimore MD 21202
http://wr.org
World Relief is sending an emergency response team to assess the situation in Port-au-Prince & to begin providing emergency assistance to the victims. The greatest needs will include food, temporary shelter, clean water, blankets, & health care. World Relief currently has staff in Port-au-Prince that will assist in the relief effort & they will work with local churches to begin the long process of recovery. World Relief works in Haiti to combat AIDS, provide basic healthcare for mothers & infants, protect orphans & at-risk children & improve financial security for vulnerable households.
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WORLD VISION, US RESPONSE TO EARTHQUAKE IN HAITI
Donation Phone: 888-56-CHILD
Donation Address:
World Vision US
34834 Weyerhaeuser Way S
PO Box 9716
Federal Way WA 98063
http://www.worldvision.org
World Vision's initial response includes distributing first aid kits to survivors, along with basic materials such as soap, blankets, clothes & water using pre-positioned emergency supplies & staff in Haiti. Global relief experts & additional supplies are being mobilized to arrive in the disaster zone as soon as possible.
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01-04-2010 : 1st WORLD CONGRESS ON CONTROVERSIES IN OPHTHALMOLOGY TO BE HELD IN PRAGUE
1st WORLD CONGRESS ON CONTROVERSIES IN OPHTHALMOLOGY TO BE HELD IN PRAGUE
http://em-sender4.com/fb/fb/D40E9D6B73CF9B80FFABE6EE66B02DDA/show.aspx
March 04-07 2010 -- Clarion Congress Hotel, Prague Czech Republic
Early Registration Deadline Ends Dec 31 2009
One of the world's most popular tourist destinations
Discuss/debate unresolved issues with leading world experts in all areas of ophthalmology
Prague Czech Republic -- Medical Industry E-Mail News™ -- Jan 04 2010 -- The 1st World Congress on Controversies in Ophthalmology (COPHy) will be held in Prague Czech Republic, event hosts announced today.
The comprehensive congress will be fully devoted to clinical debates and controversial issues in a wide spectrum of ophthalmological conditions.
Prof. Neil Bressler and Prof. Anat Loewenstein, the event Co-Chairpersons, "Invite you to take part in the World Congress, which is intended as the inaugural event of many future editions."
Background:
Over the years, ophthalmology has undergone an enormous expansion in clinical trials and basic research, as well as in cutting-edge technology. The growing challenges of ophthalmic diseases, including macular degeneration, diabetic retinopathy, cataract, refractive surgery and glaucoma, have reached epidemic dimensions, and a myriad of treatment possibilities are being explored in different directions. The fields of dry eye, refractive surgery, oculoplastics, advances in IOLs and socioeconomic issues also have contributed to the need to debate many controversial issues, which come up in clinical situations every day.
The World Congress is an exclusive forum for international experts to share and compare experiences, in order to outline the potentially best treatments for patients within these controversial areas. A Congress focusing on controversies in ophthalmology is a new concept. There is little available in the peer-reviewed literature on controversies in ophthalmology, so there is a perceived need to enable an effective debate about unresolved issues, often resulting in agreed-upon answers supported by evidence-based medicine and expert opinion.
Attendees will have the advantage of discussing and debating these unresolved issues with leading world experts in all areas of ophthalmology. The Congress aims to reach the best answers currently possible, and provide the clinician with reliable, up-to-date scientific solutions, based on the best existing evidence.
Timetable & Schedule of Topics: http://www.comtecmed.com/cophy/2010/timetable.aspx
CMEs: http://www.comtecmed.com/cophy/2010/CME.aspx
Sponsors: http://www.comtecmed.com/cophy/2010/Sponsors.aspx
Sponsorship & Exhibition: http://www.comtecmed.com/cophy/2010/sponsorship.aspx
Committees: http://www.comtecmed.com/cophy/2010/committees.aspx
General Information & Visas: http://www.comtecmed.com/cophy/2010/information.aspx
Tips & Hints: http://www.comtecmed.com/cophy/2010/tips.aspx
Accommodations: http://www.comtecmed.com/cophy/2010/CCH.aspx
About Prague: http://www.comtecmed.com/cophy/2010/about_prague.aspx
SOURCE:
COMTECMED http://www.comtecmed.com
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12-22-2009 : 19TH ANNUAL NATIONAL HEALTH BENEFITS CONFERENCE & EXPO (HBCE)
19TH ANNUAL NATIONAL HEALTH BENEFITS CONFERENCE & EXPO (HBCE)
http://www.hbce.com
Jan 25-26 2010 -- Sheraton Sand Key Resort, Clearwater Beach FL USA
Features National Thought Leaders on Reform & Showcase of Employer Success Stories
Biggest Challenge Remains: Addressing the Most Intractable Cost Problem Facing American Employers
Escape the freezing winter snows in sunny Florida & receive CMEs
Clearwater Beach FL USA -- Medical Industry E-Mail News™ -- Dec 22 2009 -- In what may be the first nationwide health benefits conference of its kind in 2010, attendees will hear an update on health reform legislation, plus the options and implications for employers and related stakeholders, on Jan 25-26 2010 at the popular HBCE annual conference at the Sheraton Sand Key Resort, Clearwater Beach FL USA.
Benefits to Attend:
Best Value in Health Benefits Continuing Education (HBCE). You can pay more at any number of conferences. But there are few, if any, where you will learn more. HBCE always features the highest quality and moderate registration rates. This event grows larger every year with continued excellent reviews.
Multiple Concurrent Sessions from Professional Peers Are Varied & of the Highest Quality:
Caterpillar -- Getting Better Value from Your Health Care Spend; Michael Taylor MD
HSN (Home Shopping Network) -- Managing Your Outside Legal Benefits Counsel
Black & Decker -- Value Based Benefits Strategy: Proven Results; Ray Brusca
L.L. Bean -- Enhancing the Well-being of Our Employees Since 1982; Susan Tufts
JM Family -- Is There a Doctor in the House? Evolution of JM Family's Health & Wellness Strategy (Onsite Clinics long before they became in vogue)
IAP Worldwide Services -- Fearless Leadership in a Fearful Environment; Mark Gow
Mayo & Novartis Employee Health -- Best Practices in Integrating Health & Productivity Initiatives; Robert Goldsmith MD & Kurt Hobbs
H-E-B -- Common Sense Approach to Value Based Benefits Design; Kathy Durbin
Lincoln Industries -- Wellness as a Business Strategy; Dan Krick
Rosen Hotels & Resorts -- Not Your Ordinary Onsite Employer Clinic
Gulf Power/Southern Co -- Creating a Culture of Wellness Within Your Company; Deborah Napier
Palm Beach County -- True Tales from a Self-Insured Public Employer with a Flat Renewal; Nancy L. Bolton
Leapfrog Group -- ROI of Hospital P4P (Pay-for-Performance): State Case Studies (particularly NJ & NV); Leah Binder, CEO
NIH -- Wellness Program Essentials & Lessons Learned from the first 2 Years in Employee Wellness at the National Heart, Lung, & Blood Institute; Dr. Rachel Levine
Creighton University -- From Fragmentation to Integration; Building a Healthier Campus
Oak Ridge National Laboratory (DOE) -- Implementation of a Comprehensive Wellness Program
City of Knoxville -- Adding Personal Responsibility to the Health Equation; Gary Eastes
State of Florida, Broward County Schools, JM Family, Sarasota County -- Reinventing Workers' Comp
Blue Lake Casino & Hotel -- Medical Tourism Coverage; Jack Norton
Ethics & Ethical Dilemmas in Health Care Claims Management
See the Complete Conference Program & To Register:
http://www.hbce.com
Award-Winning Programs & Professionals: Sample of Award Winning Speakers:
Leadership Award-Most Effective Integrated Care Program-Wellness/Disease Management
C. Everett Koop National Health Award Winners (2009) & (2008)
Pioneer Institute Award for Innovative Health Care (2009)
Benefits Professional of the Year, EBN, (2007)
Wellness Council of America (WELCOA), Two Time Platinum Award Winner, ('03) & ('06)
Benefits Leadership Award in Health Care, EBN, (2009)
Center for Disease Control (CDC) Worksite Wellness Award (2005), (2006) & (2007)
Judges' Choice Award, EBN, (2006)
Post Conference Workshops:
Impact & Implications of Health Reform
HIPAA Privacy Compliance (after ARRA) & GINA (Genetic Information Nondiscrimination Act)
Manatee County "Your Choice" Health Plan
Conference Hotel:
Sheraton Sand Key Resort. After you have registered for the HBCE, call the Hotel directly: 727-595-1611 for the special Conference rate during snowbird season of $179 (single or double) -- or register online at the link below. There is no charge for parking and no resort fee at this beautiful hotel, located directly on the white sand beach. See the hotel and register at:
http://www.starwoodmeeting.com/StarGroupsWeb/res?id=0906250795&key=4F2C1
Airport:
Situated convenient to the Tampa Intl Airport (TPA), consistently rated as one of the best airports in the US.
Continuing Education Credits:
SHRM (Society for Human Resource Management). This program will be submitted for PHR, SPHR and GPHR recertification credits (always approved in the past -- 8.5 HRCI credit hours). Application has also been made to the AAOHN and to NCHEC for CHES continuing education credits. For others, a Certificate of Attendance will be provided upon request.
Employer Registration Early** Late-after 1/20***
First Person $295 $275 $345
Second Person $275 $250 $325
Third Person $250 $225 $295
Fourth Person Gratis
Commercial Registration* $345 $325 $395
Second Person $325 $295 $375
Third Person $295 $275 $345
Fourth Person Gratis
*Consultant or supplier of health services or other products/services to employers.
**Early registrations means received before Dec 31 2009
***Add 50 if registered onsite
Satisfaction is assured or registration refunded
Post Conference Workshop:
Employer $65 - $75 - $85 (later) & Commercial - $75 - $85 - $95 (later)
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
HBCE CONFERENCE REGISTRATION FORM:
info@HBCE.com
Please answer questions below & send
Or use the registration form at http://www.hbce.com
Or submit the below info via one of the following:
941-484-1430 phone
941-484-1410 fax
Name _________________________________________________
Title _________________________________________________
Employer ______________________________________________
Address _______________________________________________
______________________________________________________
Phone:_______________________Fax:_____________________
Email: ________________________________________________
PAYMENT OPTIONS:
1. INVOICE Please invoice/bill my company_____
2. CARD: MC______VISA_______AMEX_______
Card #:______________________________________Exp. Date_______
CVV #: 3 #s on back (except AMEX 4 #s on front) _________________
Total Amount:__________ Name on Card:_________________________
Signature: ___________________________________________________
3. CHECK: Please make checks payable to: Health Benefits Conference & Expo (HBCE)
SOURCE:
Health Benefits Conference & Expo (HBCE)
http://www.hbce.com
Best Value in Health Benefits Continuing Education (HBCE)
Join the Best Purchasers, Peers & Partners
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12-21-2009 : 1st WORLD CONGRESS ON CONTROVERSIES IN OPHTHALMOLOGY TO BE HELD IN PRAGUE
1st WORLD CONGRESS ON CONTROVERSIES IN OPHTHALMOLOGY TO BE HELD IN PRAGUE
http://www.comtecmed.com/cophy/2010
March 04-07 2010 -- Clarion Congress Hotel, Prague Czech Republic
Early Registration Deadline Ends Dec 31 2009
One of the world's most popular tourist destinations
Prague Czech Republic -- Medical Industry E-Mail News™ -- Dec 21 2009 -- The abstract submission deadline ends Dec 31 2009 for the 1st World Congress on Controversies in Ophthalmology (COPHy) to be held in Prague Czech Republic, event hosts announced today.
The comprehensive congress will be fully devoted to clinical debates and controversial issues in a wide spectrum of ophthalmological conditions.
Prof. Neil Bressler and Prof. Anat Loewenstein, the event Co-Chairpersons, "Invite you to take part in the World Congress, which is intended as the inaugural event of many future editions."
Background:
Over the years, ophthalmology has undergone an enormous expansion in clinical trials and basic research, as well as in cutting-edge technology. The growing challenges of ophthalmic diseases, including macular degeneration, diabetic retinopathy, cataract, refractive surgery and glaucoma, have reached epidemic dimensions, and a myriad of treatment possibilities are being explored in different directions. The fields of dry eye, refractive surgery, oculoplastics, advances in IOLs and socioeconomic issues also have contributed to the need to debate many controversial issues, which come up in clinical situations every day.
The World Congress is an exclusive forum for international experts to share and compare experiences, in order to outline the potentially best treatments for patients within these controversial areas. A Congress focusing on controversies in ophthalmology is a new concept. There is little available in the peer-reviewed literature on controversies in ophthalmology, so there is a perceived need to enable an effective debate about unresolved issues, often resulting in agreed-upon answers supported by evidence-based medicine and expert opinion.
Attendees will have the advantage of discussing and debating these unresolved issues with leading world experts in all areas of ophthalmology. The Congress aims to reach the best answers currently possible, and provide the clinician with reliable, up-to-date scientific solutions, based on the best existing evidence.
Early Registration Deadline Ends Dec 31 2009: http://www.comtecmed.com/cophy/2010/Registration.aspx
Timetable: http://www.comtecmed.com/cophy/2010/timetable.aspx
CMEs: http://www.comtecmed.com/cophy/2010/CME.aspx
Sponsors: http://www.comtecmed.com/cophy/2010/Sponsors.aspx
Sponsorship & Exhibition: http://www.comtecmed.com/cophy/2010/sponsorship.aspx
Committees: http://www.comtecmed.com/cophy/2010/committees.aspx
General Information & Visas: http://www.comtecmed.com/cophy/2010/information.aspx
Tips & Hints: http://www.comtecmed.com/cophy/2010/tips.aspx
Accommodations: http://www.comtecmed.com/cophy/2010/CCH.aspx
About Prague: http://www.comtecmed.com/cophy/2010/about_prague.aspx
Abstract Submission: http://www.comtecmed.com/cophy/2010/Abstract_Submission.aspx
Preliminary Scientific Program: http://www.comtecmed.com/cophy/2010/sci_program.aspx
Issues Include:
Acanthamoeba
Accessibility of retinal degenerations to gene therapy
Advanced high-risk PDR: PRP initially, or PRP w/anti-VEGF drugs or anti-VEGF
drugs alone, or go right to vitrectomy?
Dermis-fat grafts are an unnecessarily complicated way of socket
rehabilitation?
Diabetic retinopathy & cataract: Combined surgery vs cataract performed
separately
Do porous implants have any role in sockets in this day-and-age?
Does a patient w/Horner Syndrome require pharmacologic testing to localize
the lesion?
Does a patient w/NAION need coagulation systemic evaluation?
Does amiodarone cause an ischemic optic neuropathy?
Does radiation therapy improve patients with thyroid eye disease?
Early repair of blowout fractures is essential?
Full thickness & lamellar macular holes, epiretinal membranes, vitreomacular
traction syndrome
Fungal keratitis
Herpes simplex/zoster
How should post-surgical cystoid macular edema be treated? First line
therapy: What if topical nonsteroidal & topical steroidal drops are not working?
How should retinal detachment from colobomas (including optic pits) be
managed?
How should 3 diopters of astigmatism be treated?
How soon should DCR be performed after acute dacryocystitis?
If edema is being treated w/anti-VEGF, & there is iris neovascularization,
is PRP also indicated while providing anti-VEGF? When anti-VEGF is discontinued?
If treating diabetic macular edema w/an anti-VEGF drug in the setting of
retinal neovascularization, do you also do PRP if there is PDR or wait until the
anti-VEGF drug is discontinued?
Is a fluorescein angiogram needed?
Is a medical work-up indicated?
Lattice degeneration prior to cataract surgery: Should prophylactic laser be
used?
Magnetic resonance vengraphy or CT venography for presumed idiopathic
intracranial hypertension?
MICS: technique & lenses
Mohs tumor resection should be used for all tumors?
1-stitch vs 3-stitch ptosis correction
Pan-retinal photocoagulation techniques: mild scatter or full scatter;
indirect or slit-lamp delivery; automated mode delivery (e.g., Pascal laser) or
manual delivery?
Persistent subretinal fluid after buckling for retinal detachment
Radiotherapy is valuable treating thyroid eye disease?
Relaxing incisions (blade or laser)
Serous macular detachment from an optic pit
Should a patient w/giant cell arteritis have a unilateral or bilateral
temporal artery biopsy?
Should an IOL be implanted?
Should congenital lacrimal fistulae have a DCR as well as fistula excision?
Should possible pleomorphic adenomas be biopsied?
Should posterior approach ptosis repair be retired from service?
Should PRP be placed right away?
Should stenting be offered to patients w/presumed idiopathic intracranial
hypertension & venous sinus thrombosis?
Should the fellow eye be treated?
Should traumatic optic neuropathy be treated? If so: When & how?
Should we perform posterior capsulorhexis?
Surgical approach to choroidal neovascularization management secondary to
age-related macular degneration
Technique & instruments, clear corneal incision: temporal, superior,
oblique?
Toric phakic IOL
Use of Restasis: is there confidence that it works?
What is the best surgical approach for juvenile rheumatoid arthritis
associated cataract?
What is the role of intravitreal steroids in uveitis?
What is the role of relaxing retinotomies in severe proliferative
vitreoretinopathy?
What is the role of vitreoretinal surgery in uveitis?
When should a post-laser assisted in situ keratomileusis (LASIK)
keratoectatic eye be treated?
When should an unstable keratoconus eye be treated?
Debates Include:
Best Way To Perform Flap Is Mechanical Microkeratome For Femtosecond Laser?
Effect Of Cataract On Diabetic Retinopathy
Effect Of Cataract On Macular Degeneration
Management In Branch Vein & Central Vein Occlusion
Management Of Childhood Epiphora: Probing, Intubation Or DCR?
Management Of Unilateral Severe Childhood Ptosis
Nystagmus Surgery
Optimal Management Of Uveitis
Preoperative Care
Presbyopia Correction Iols
Proton Beam vs External Beam Radiotherapy For Retinoblastoma
Refractive Surgery In Children
Scleritis: How Should It Be Treated?
Screening Of Patients For Various Eye Disease
Should A Patient w/Acute Optic Neuritis & White Matter Lesions Be Treated
For Multiple Sclerosis & How?
Should We Buckle Or Perform Vitrectomy?
Should We Perform Systemic Evaluation?
Sight Threatening Central Corneal Ulcer: What Is The Best Treatment?
Simultaneous Management Of Bilateral Cataracts
Small Pupil: Surgical Options
Strabismus Surgery
Subluxated Intraocular Lenses
Surgery For Diabetic Maculopathy
Target Pressure: Essential Tool Or Cookie-Cutter Medicine?
Thyroid Related Strabismus
Timing Of Vitrectomy In Posterior Segment Trauma
To Peel Or Not To Peel The Internal Limiting Membrane
Traumatic Cataract In Adults & Children
Treatment Of Advanced Retinoblastoma
Using Optical Coherence Tomography To Manage Diabetic Macular Edema
What Is Best Conservative Management Of Uveal Melanoma?
What Is Best Management For Nonareteritic Optic Neuropathy?
What Is Best Management For Pseudotumor Cerebri?
What Is Optimal Treatment Of Neovascular Macular Degeneration?
What Treatment Should Be Used In Conjunction With Focal/Grid Laser?
When To Treat Ocular Hypertension?
Panel Discussions Include Controversial Cases In:
Cataracts In Children
Central Vein Occlusion w/Nonperfusion
Corneal Disease
Idiopathic Intracranial Hypertension & Other
Lids & Lacrimal
Orbits & Sockets
Proliferative Diabetic Retinopathy
Retina & Cataract
Retinal Detachment
Selected Questions In Neuroophthalmology
Treating Keratoconus & Keratecsasia & Astigmatism Correction
Uveitis
SOURCE:
Ms. Nitza Cohen
Project Mgr
53 Rothschild Blvd PO Box 68
Tel Aviv 61000 Israel
011-972-3-566-6166 phone
011-972-3-566-6177 fax
cury@comtecmed.com
nitza@comtecmed.com
http://www.comtecmed.com
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12-17-2009 : 3rd WORLD CONGRESS ON CONTROVERSIES IN UROLOGY TO BE HELD IN HISTORIC ATHENS
3rd WORLD CONGRESS ON CONTROVERSIES IN UROLOGY TO BE HELD IN HISTORIC ATHENS
http://comtecmed.com/cury/2010/sci_program.aspx
-- Feb 25-28 2010 -- Hilton Hotel, Athens Greece
-- Almost 100 leading experts from around the world to speak
Athens Greece -- Medical Industry E-Mail News™ -- Dec 17 2009 -- The deadline for abstract submissions has been extended to ends Dec 20 2009 for the 3rd World Congress on Controversies in Urology (CURy), event hosts announced today.
Benefit from the experiences and opinions of almost 100 world-renowned experts on a wide spectrum of urological conditions, note Scientific Committee Chairpersons Professors Gerasimos Alivizatos, Jacob Ramon and Claude Schulman.
The popular congress will be held in historic Athens Greece, on Feb 25-28 2010, at the luxurious Hilton Hotel in the heart of this unforgettable city. Events will be held in sight of the breathtaking Acropolis, near the stunning new Acropolis Museum, in the center of the birthplace of western civilization. And of course, there is nothing quite like the celebratory nightlife in downtown Athens, savory dining and warmth of the hospitality.
The Hilton Athens hotel is situated in the commercial district and is just
45 minutes from the airport. All rooms have balconies with city views.
Tourist attractions in Athens are near the hotel, and include the Acropolis,
Temple of Theseus and shopping in Kolonaki.
Background:
Following the success of the first two meetings of the World Congress on Controversies in Urology (CURy), the 3rd World Congress will disseminate information, discuss and debate controversial issues in the continuously evolving field of urology. The Congress promises innovative approaches in communication with substantial discussion and debates.
Each year, new advances in research and medical technology in urology and related fields raise new controversial issues, which should be addressed.
The 3rd World Congress will highlight many of these key new issues in order to reach ultimate state-of-the-art solutions, and to provide clinicians with conclusive recommendations and reliable solutions, all based on current up-to-date knowledge.
Abstracts:
Abstracts: The final deadline for abstract submission is Jan 01 2010
http://comtecmed.com/cury/2010/abstracts.aspx
Registration:
http://comtecmed.com/cury/2010/Registration.aspx
CMEs:
http://comtecmed.com/cury/2010/CME.aspx
Sponsors:
http://comtecmed.com/cury/2010/sponsors.aspx
Accommodations:
http://comtecmed.com/cury/2010/Accommodation.aspx
Visas & General Information:
http://comtecmed.com/cury/2010/general.aspx
Faculty from the 2009 Congress:
A. Alcaraz, Spain G. Guazzoni, Italy P. Perrin, France
C. Barre, France V. Grunwald, Germany T. Piechaud, France
H.W. Bauer, Germany R. Hautmann, Germany J. Pinthus, Canada
J. Bellmunt, Spain J. Heesakkers, Netherlands F. Porpiglia, Italy
R. Berges, Germany H. Huland, Germany D. Pushkar, Russia
L. Boccon-Gibod, France V. Hupertan, France J. Ramon, Israel
Liliane Boccon-Gibod, France J. Irani, France P. Rischmann, France
A. Borkowski, Poland P. Iversen, Denmark D. Robinson, UK
H. Botto, France V. Khullar, UK F. Saad, Canada
M. Brausi, Italy Z. Kirkali, Turkey C. Schulman, Belgium
R. Bollens, Belgium J. Larkin, UK A. Sella, Israel
M. Burger, Germany E. Lima, Portugal I. Sinescu, Romania
J.R. Cerda, Spain C. Llorente, Spain E. Solsona, Spain
M. Colombel, France M. Marberger, Austria M. Sosnowski, Poland
E. Comperat, France K. Miller, Germany M. Speakman, UK
G. Cozma, Switzerland V. Mirone, Italy A. Stenzl, Germany
F. Cruz, Spain F. Montorsi, Italy C. Sternberg, Italy
P. Dinis, Portugal A. Martin Morales, Spain U. Studer, Switzerland
F. Debruyne, Netherlands N. Mottet, France D. Tolley, UK
F. Desgrandchamps, France A. Mottrie, Belgium B. Tombal, Belgium
A. de la Taille, France P. Mulders, Netherlands J. Tostain, France
Z. Dotan, Israel K.G. Naber, Germany O. Traxer, France
S. Egawa, Japan A. Nadu, Israel A. Tubaro, Italy
A. Finelli, Canada O. Nativ, Israel L. Turkeri, Turkey
A. Figueiredo, Portugal M. Oelke, Germany P. Veindeira, Portugal
J. Fitzpatrick, Ireland H. Ozen, Turkey E. Wespes, Belgium
N. Fleshner, Canada R. Palma, Brazil F. Witjes, Netherlands
Y. Fradet, Canada B. Parada, Portugal M. Zitzmann, Germany
P. Geavlete, Romania J. Palou, Spain A. Zlotta, Canada
TENTATIVE SCHEDULE:
Friday, Feb 26 2010
Session 1
PROGRESS IN MINIMALLY INVASIVE SURGERY (MIS):
IS LAPARO-ENDOSCOPIC-SINGLE-SITE SURGERY (LESS) THERE TO STAY?
An unrestricted educational grant by Olympus Medical Systems Europa (GMBH)
Chairpersons:
J.-U. Stolzenburg, Germany & E. Liatsikos, Greece
Welcome & Introduction
J.-U. Stolzenburg, Germany
LESS instrumentation & evaluations
E. Liatsikos, Greece
LESS: A review
M. Desai, USA
LESS: Transvaginal Access
A. Alcaraz, Spain
LESS & its future: Tumor Nephrectomies
J.-U. Stolzenburg, Germany
LESS: In Gynecology
G. Scambia, Italy
LESS: In General Surgery
H. Weiss, Austria
Summary & Discussion
J.-U. Stolzenburg, Germany
Session 3
MEASURING OUTCOMES IN OAB: Past, Present & Future
An unrestricted educational grant by Astellas Pharma Europe Ltd
Chairperson:
D. de Ridder, Belgium
Debate: Urodynamics remains the gold standard for assessment & measurement
Pro: A. Apostolidis, Greece
Con: P. Radziszewski, Poland
Debate: Patient reported outcomes are the most important & relevant way of measuring success
Pro: E. Constantini, Italy
Con: M. Speakman, UK
Debate: The use of biomarkers will become standard in the management of OAB in the future
Pro: C. Fowler, UK
Con: F. Cruz, Portugal
Session 5
DISCUSSION ON KEY CONTROVERSIES IN THE MANAGEMENT OF PROSTATE CANCER
Satellite Symposium by Astellas Pharma Europe Ltd.
Chairperson:
L. Boccon-Gibod, France
Introduction
Chair
Multidisciplinary care in prostate cancer: what’s the added value?
B. Tombal, Belgium
Testosterone monitoring in prostate cancer: is it important?
C. Schulman, Belgium
Early management of prostate cancer: when & how?
J. Irani, France
Treatment of advanced prostate cancer: can we reduce the impact on the patient’s quality of life?
T. Oliver, UK
Discussion & take home messages
Chair, faculty & participants
Session 6
CONTROVERSIES IN THE MANAGEMENT OF MALE LUTS:
Go with the flow or go for the patient
An unrestricted educational grant by Astellas Pharma Europe Ltd
Chairperson:
F. Debruyne, The Netherlands
It’s all about LUTS: Controversies in the aetiology & diagnosis of LUTS in male patients
Patient case discussion: Chairman & Audience
Evidence lecture: K. Stravodimos, Greece
Disrupted sleep in male LUTS patients: The neglected consequence of nocturia?
Patient case discussion: Chairman & Audience
Evidence lecture: N. Stanley, UK
Male LUTS: Is individualizing treatment against the flow?
Patient case discussion: Chairman & Audience
Evidence lecture: P. van Kerrebroeck, The Netherlands
Session 8
PROSTATE CANCER PREVENTION, SCREENING & EARLY DIAGNOSIS
Chairpersons: S. Egawa, Japan & Y. Fradet, Canada
Prevention rational: What have we learned from the PCPT & REDUCE trials?
N. Fleshner, Canada
Which other possible prevention options?
S. Horie, Japan
Who should be screened?
P. Rischmann, France
Potential role of diagnostic markers
Y. Fradet, Canada
Session 2
PROSTATE CANCER: RISING PSA AFTER TENTATIVE CURATIVE TREATMENT
Chairpersons: L. Klotz, Canada; A. Rombis, Greece
Welcome
A. Rombis, Greece
Rising PSA after radical prostatectomy
What is the correct PSA threshold to define failure after surgery: Is there a role for anastomotic biopsy?
Management with XRT: When, to whom, how much?
Hormonal therapy: When to initiate?
Is there a place for surveillance?
Rising PSA after brachytherapy / radiation
Definition of biochemical failure
Is there a role for prostate biopsy?
Management with surgery: When, to whom?
Management with hormonal therapy: Early vs. delayed
Combination therapy?
Is there a place for surveillance?
Can MRI & Spectroscopy help in active surveillance?
Speakers:
J. Anderson, UK
L. Boccon-Gibod, France
F. Debruyne, The Netherlands
Z. Dotan, Israel
S. Egawa, Japan
J. Moul, USA
H. Payne, UK
W. Oosterlinck, Belgium
Session 4
BLADDER CANCER: NONMUSCLE INVASION
RECURRENCE UNDER TREATMENT: WHICH DIFFERENT OPTIONS?
An unrestricted educational grant by Kyowa Kirin
Chairpersons:
J. Palou, Spain & A. Skolarikos, Greece
Immediate treatment: When? For which patients?
Recurrence under treatment: Which are the different options?
Prognostic factors
Speakers:
M. Brausi, Italy
F. Witjes, The Netherlands
W. Oosterinck, Belgium
Satellite Symposium
Session 7
TESTICULAR CANCER MANAGEMENT
Chairpersons: F. Sofras, Greece
Debate: Testicular-sparing surgery
For: TBA
Against: V. Matveev, Russia
Debate: Therapeutic options for stage-I seminoma
Surveillance: A. Bamias, Greece
Irradiation: H. Payne, UK
Chemotherapy: J. Bellmunt, Spain
Debate: Treatment options for stage-I non-seminomatous tumors
Surveillance: TBA
Surgery: U. Studer, Switzerland
Chemotherapy: J. Bellmunt, Spain
RPLND: Panel discussion
Post-chemotherapy only?
Experience with laparoscopic RPLND
Panel:
A. Bamias, Greece
V. Matveev, Russia
U. Studer, Switzerland
A. Stenzl, Germany
H. Payne, UK
Session 9
RENAL TUMORS: CASE DISCUSSION DEBATE
Chairperson:
M. Marberger, Austria
Panel:
A. Bamias, Greece
J. Fitzpatrick, UK
V. Matveev, Russia
A. Mottrie, Belgium
M. Soloway, USA
C. Sternberg, Italy
J.-U. Stolzenburg, Germany
Saturday, Feb 27 2010
Session 10
NONMUSCLE INVASIVE BLADDER CANCER
TUR quality control, How to improve outcomes,
Controversies in the management of T-1 disease
An unrestricted educational grant by General Electric (GE)
Chairpersons: M. Soloway, USA & M. Melekos, Greece
Quality control of TURB
M. Soloway, USA
Can we improve TURB?
P. Geavlete, Romania
Improving outcomes & the role of Hexvix in reducing recurrence
D. Zaak, Germany
Controversies in T1 disease
When Re-TURBT is indicated?
When a radical cystectomy should be considered?
Can we improve intravesical therapy?
TBA
F. Witjes, The Netherlands
Session 12
STRATEGIES FOR OPTIMIZING OUTCOMES IN GU MALIGNANCIES
Supported by Novartis Oncology
Chairpersons: G. Moutzouris, Greece; F. Saad, Canada
Introduction: Importance of bone health in GU cancers: G. Moutzouris, Greece
Optimal outcomes in metastatic RCC & bladder cancer: U. Tunn, Germany
Optimal outcomes in metastatic prostate cancer: M. Colombel, France
Anticancer effects of Zoledronic acid (ZOL): F. Saad, Canada
Q&A:
Factors that contribute to optimal outcomes in advanced GU malignancies (value of bone health)
-Pain reduction
-Increased QoL
-Cost effectiveness
-Effective even in late-stage disease
Potential anti-cancer properties of bisphosphonates (BPs) in GU malignancies
-ZOL anticancer mechanism of action: Data in prostate, kidney & bladder cancers
Session 14
GnRH RECEPTOR BLOCKADE: NEW APPROACH TO PROSTATE CANCER MANAGEMENT
An unrestricted educational grant by Ferring
Chairpersons: J. Anderson, UK; I. Vakalopoulos, Greece
Welcome & Objectives
Clinical development of a new GnRH blocker
B.-E. Persson, Switzerland
Firmagon vs. leuprolide: What is the difference?
B. Tombal, Belgium
Which patients will benefit from GnRH blocker therapy?
J. Anderson, UK
Neoadjuvant/adjuvant hormonal treatment
H. Payne, UK
Conclusions
J. Anderson, UK
Session 16
KEY CONTROVERSIES IN ADVANCED GU CANCERS
An unrestricted educational grant by Sanofi Aventis
Chairpersons: J. Fitzpatrick, UK & C. Sternberg, Italy
Session 18
BPH SURGICAL MANAGEMENT: Green light laser session on the treatment of outflow obstruction
An unrestricted educational grant by American Medical Systems
Chairperson:
G. Alivizatos, Greece
Why do we need an alternative to the gold standard, TURP, in the first place?
Why is the evidence from published papers that the Green light laser is effective?
Can we treat big prostates & big middle lobes with the Green light laser?
Tips, tricks & pearls for successful GL patient outcomes
No tissue, no biopsy with the Green light laser: Is that a problem?
Patients under anticoagulation therapy & patients in retention: Can we treat them?
Why is the Green light laser better surgical treatment alternative than traditional TURP?
What are the major differences from other lasers?
Is it possible that lasers might compete with medical treatment in the future?
Session 11
MEN'S HEALTH
Chairpersons: D. Hatzichristou, Greece & E. Wespes, Belgium
Endothelial dysfunction
E. Wespes, Belgium
Which ED patients are at cardiovascular risk?
R. Virag, France
Daily dose vs. on demand PDEF-I after prostatectomy
A. Salonia, Italy
Session 13
MINIMAL & LOCALIZED PROSTATE CANCER
Chairpersons: J. Irani, France & A. Deliveliotis, Greece
Debate: Selecting patients for active surveillance: Should present criteria be enlarged or reduced?
L. Klotz, Canada
J. Moul, USA
Debate: Triggers for therapy in patients on active surveillance
Is PSA kinetics sufficient to trigger therapy?
Is there a role for diagnostic markers?
Prostate biopsy in AS
Should imaging be added to PSA kinetics?
Can 5-Alpha-Reductase influcnece patients' selection?
Panel:
Y. Fradet, Canada
N. Fleshner, Canada
M. Soloway, USA
Debate: Radiation + Hormone: Is the survival benefit balanced by the side effects?
H. Payne, UK
Z. Symon, Israel
Session 15
MALE INCONTINENCE: CLINICAL CASES
Chairperson: F. Cruz, Portugal & L. Boccon-Gibod, France
How big is the problem & how should it be handled?
L. Boccon-Gibod, France
Incontinence after RT?
D. de Ridder, Belgium
Surgical options: Pros & Cons
AUS: J. Heesakkers, The Netherlands
Invance: P. Dinis, Portugal
Obturator tapes: D. Waltregny, Belgium
ProAct balloons: P. Radziszewski, Poland
Discussion: With clinical cases
Facilitated by: F. Cruz, Portugal
Session 17
ENDOUROLOGY & NEPHROLITHIASIS
An unrestricted educational grant in part by Storz
Chairpersons: P. Geavlete, Romania & D. Mitropoulos, Greece
Debate: Supine vs. prone position during PCNL
Supine position: P. Conort, France
Prone position: R. Scarpa, Italy
Debate: Difficult situation: Is there a limit?
Moderator: M. Marberger, Austria
Panel:
P. Conort, Frace
R. Scarpa, Italy
A. Skolarikos, Greece
H. Winkler, Israel
Session 19
LOCALLY ADVANCED BLADDER CANCER: CASE DISCUSSION
Chairpersons: A. Zlotta, Canada & A. Antoniou, Greece
Neoadjuvant or adjuvant chemotherapy when the renal function is impaired: for some patients, for all patients, for no patient?
A. Bamias, Greece
Locally advanced bladder cancer: When the margins are positive
M. Soloway, USA
Case discussion:
Does surgery offer some hope of cure when the nodes are grossly positive?
Contraindications to neo-bladder reconstruction
Management of advanced bladder cancer with hydronephrosis & kidney failure
Panel:
A. Bamias, Greece
Y. Fradet, Canada
M. Soloway, USA
U. Studer, Switzerland
Sunday, Feb 28 2010
Session 20
URINARY DIVERSION
Chairpersons: R. Hautmann, Germany & S. Horie, Japan
Urinary diversion following cystectomy for bladder cancer: Advantages & disadvantages
Conduits: M. Marberger, Austria
Orthotopic diversion in males: U. Studer, Switzerland
Orthotopic diversion in females: W. Mansson, Sweden
Anal sphincter diversion: H. Botto, Frace
Case discussion
Presenter: R. Hautmann, Germany
Conclusion
R. Hautmann, Germany
Session 21
LOOKING AT OUTCOMES
Surgery for bladder & prostate cancer
Open vs. LAP vs. Robotic
Chairpersons: A. Alcaraz, Spain & U. Studer, Switerland
Topics:
Operative time & hospital stay
Complications
Lymph node dissection
Progression free survival
Cancer-specific survival
Overall survival
Urinary continence
Continence with orthotopic diversion
Potency preservation
Surgical margins
Panel:
C. Barre, France
S. Egawa, Japan
R. Hautmann, Germany
A. Mottrie, Belgium
T. Piechaud, France
M. Soloway, USA
J.-U. Stolzenberg, Germany
A. Zlotta, Canada
About the Venue:
The history of Athens is one of the longest of any city in Europe & in the world. Athens has been continuously inhabited for at least 3,000 years, becoming the leading city of Ancient Greece in the first millennium BCE. its cultural achievements during the 5th century BCE laid the foundations of western civilization.
Thanks to the fortunes brought by the 2004 Summer Olympics, modern Athens is a reformed city with spotless parks and streets. As Greece's capital, it offers all the attractions of a big city, as well as many sites belonging to the pillars of Western history, from the Acropolis to the Temple of Olympian Zeus. It is a unique blend of Middle Eastern and Western cultures.
SOURCE:
Ms. Nitza Cohen
Project Manager
53 Rothschild Boulevard PO Box 68
Tel Aviv 61000 Israel
011-972-3-566-6166 phone
011-972-3-566-6177 fax
nitza@comtecmed.com
http://www.comtecmed.com
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12-16-2009 : SMALL BONE INNOVATIONS, INC. SECURES $30MM CREDIT FACILITY
SMALL BONE INNOVATIONS, INC. SECURES $30MM CREDIT FACILITY
http://www.totalsmallbone.com
Supports a more rapid worldwide S.T.A.R.® total ankle replacement system roll-out than previously planned
Supports expansion of core business & planned introduction of new products & product enhancements in 2010
Company to expand clinical studies of top products
Refinances existing indebtedness
New York NY USA -- Medical Industry E-Mail News™ -- Dec 16 2009 -- Small Bone Innovations, Inc. (SBi), a leading, privately held orthopedics company focused exclusively on technologies and treatments for the small bones & joints, has closed on a $30mm credit facility to fund accelerated business expansion and refinance existing indebtedness. The senior, secured credit facility was provided by Drawbridge Special Opportunities Fund, a fund managed by an affiliate of Fortress Investment Group, a global investment management firm headquartered in New York City.
The credit facility has allowed SBi to fully repay approximately $13 million of its existing debt, and will enable the company to build upon its core business by funding the introduction in 2010 of several new products and improved versions of existing products for both the upper and lower limb anatomies. The company said it also plans to build-out instrument sets to further support its product portfolio. The funding will also support SBi's focus on evidence-based medicine, by developing and initiating several studies to better support clinical understanding of its product portfolio.
"Since the FDA-approved 'Indications for Use' demonstrating S.T.A.R.® as superior in efficacy and comparable in safety to ankle fusion, and our U.S. introduction of the S.T.A.R.® ankle earlier this year, demand for uncemented total ankle replacement systems in both domestic and overseas markets has exceeded our sales plan," said Anthony G. Viscogliosi, Chairman & CEO of SBi. "Consequently, SBi intends to accelerate manufacture of both implants and instrument sets by bringing forward capital investment in the S.T.A.R.® system and expanding its surgeon education and training programs.
"Furthermore, these developments are expected to have a favorable corollary effect on the funding of several other product introductions and enhancements planned for 2010. Obviously, these events are highly encouraging for our business during this period of an extremely weak global economy and uncertainty in all aspects of health care in the U.S.," Mr. Viscogliosi added.
Helmut D. Link and the investor group of Link America, Inc. made an equity investment in SBi in conjunction with the closing of this credit facility. Mr. Link said: "Under the leadership of Mr. Viscogliosi and all of the team at SBi, I am confident that the S.T.A.R.® ankle can realize its full potential and change the standard of care from fusion to total joint replacement, as we had envisioned when we developed this product for FDA approval and sale in the U.S."
Mr. Link added: "Under SBi ownership, the S.T.A.R.® ankle can become the centerpiece of the company's lower limb product portfolio and it enhances sales opportunities for the entire SBi product portfolio. I am very pleased and highly encouraged with the market response following the FDA PMA approval of the S.T.A.R.® ankle and foresee the case for further rapid expansion.
"Additionally, I believe that SBi's surgeon education and training programs are thorough and well executed. For the above reasons, the Link America investor group and I have decided to make an investment in the company." he concluded.
About Small Bone Innovations, Inc.
Small Bone Innovations, Inc. (SBi) was founded in 2004 by Viscogliosi Brothers, LLC, (VB), a New York-based merchant banking firm that specializes in the musculoskeletal/orthopedics sector. VB created SBi as the first company to focus purely on small bones & joints. By integrating established companies and professionals in the field, SBi offers a broad, clinically proven portfolio of products and technologies to treat trauma and diseases in small bones & joints. Today, SBi has facilities in New York NY, Morrisville PA, Bourg-en-Bresse France, Donaueschingen Germany, and Kuala Lumpur Malaysia, among other locations worldwide.
For more information on SBi, please visit: http://www.totalsmallbone.com
Forward-looking statements
This news release contains forward-looking statements as defined in the U.S. Private Securities Litigation Reform Act of 1995. Readers are cautioned not to place undue reliance on these forward-looking statements. Actual results may differ materially from those indicated by these forward-looking statements as a result of risks and uncertainties impacting SBi's business including increased competition; the ability of SBi to expand its operations and to attract and retain qualified professionals; technological obsolescence; general economic conditions; and other risks.
SOURCE:
Small Bone Innovations, Inc.
505 Park Ave 14th Fl
New York NY USA 10022
http://www.totalsmallbone.com
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12-08-2009 : FDA SELECTS QUALITY MANAGEMENT SYSTEM SOFTWARE USED BY SYNCARDIA
FDA SELECTS QUALITY MANAGEMENT SYSTEM SOFTWARE USED BY SYNCARDIA
http://www.syncardia.com
Tucson AZ USA -- Medical Industry E-Mail News™ -- Dec 08 2009 -- On Oct. 29, MasterControl announced it has been selected as the new quality management system for the Food & Drug Administration (FDA). MasterControl also provides the quality management system for SynCardia Systems, Inc., manufacturer of the SynCardia temporary CardioWest™ Total Artificial Heart.
“The FDA will find a familiar system at SynCardia,” said Rodger Ford, SynCardia President and CEO. “We reviewed more than 30 quality management systems before finally selecting MasterControl in 2005. Since the validation and launch of the software in 2006, it has been the electronic backbone of all SynCardia quality documents.”
MasterControl will be used by the FDA's Office of Regulatory Affairs (ORA) agencies that are engaged in field investigations enforcement and scientific laboratory analysis of field samples. The system will be implemented across the US, in regional offices, district offices, laboratories and headquarters.
“At SynCardia, MasterControl has allowed a small group of people to achieve extraordinary results,” said Ford. “We have only 42 employees, but through MasterControl, we touched 5,500 documents last month. This system allows us to be efficient, accountable and responsive so that we can focus on the needs of our customers... patients and physicians around the world.”
Originally used as a permanent replacement heart, the Total Artificial Heart is currently approved as a bridge to human heart transplant for patients dying from end-stage biventricular failure. The Total Artificial Heart is the only device that provides immediate, safe blood flow of up to 9.5 L/min through both ventricles.
The SynCardia Total Artificial Heart is the first and only FDA, Health Canada and CE Mark approved Total Artificial Heart in the world. There have been more than 800 implants of the Total Artificial Heart, accounting for more than 170 patient years of life on the device.
SOURCE:
SynCardia Systems Inc
http://www.syncardia.com
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12-03-2009 : ExL Pharma's Leading European Digital Marketing & PR Conference to be Hosted @ Bayer Schering
EXL PHARMA'S LEADING EUROPEAN DIGITAL MARKETING & PUBLIC RELATIONS
CONFERENCES TO BE HOSTED AT BAYER SCHERING
-- March 29-30 2010 -- Berlin Germany
http://www.exlpharma.com
New York NY USA -- Medical Industry E-Mail News™ -- Dec 03 2009 -- Bayer Schering Pharma and ExL Pharma today announced that the 2nd Annual Digital Pharma Europe and 2nd Annual European Public Relations & Communications Summit will be hosted at the Bayer Schering Pharma World Headquarters in Berlin, Germany on March 29-30 2010.
These events which feature 50+ executive-level speakers from top industry leaders provide comprehensive presentations, panel discussions and opportunities for dialogue on issues that are most relevant to social media, web 2.0 technologies, product communications and corporate communications. 300+ executives are expected to attend from leading pharmaceutical, biotech and medical device organizations worldwide.
Bryon Main, Managing Director of ExL Pharma, states, "Coming off the heels of ExL's successful European pharmaceutical conferences this year, we are very pleased to be partnering with Bayer Schering Pharma for our 2nd Public Relations and 2nd Digital Pharma Summits. This marks the first time that major industry education conferences will be hosted by a leading pharmaceutical organization in Europe."
These events will provide concrete strategies for a range of timely topics relevant to digital marketing and PR professionals, including how to build an organizational plan around social media and to prepare for and anticipate change within internal and external communications.
Past attendees of this conference had the following to say about their experiences at these events:
"This conference was excellent. Top notch speakers and terrific networking opportunities with industry colleagues."
-- Susan Watkins, PR Director, Sanofi Pasteur
"This conference was very comprehensive. We will definitely attend again next year."
-- Tricia Moriarty, Director of Commercial Communications, Sepracor
About ExL Pharma:
ExL Pharma, a division of ExL Events, Inc., is an international leader in developing innovative, educational events that serve the healthcare community and allied professionals. Behind our diverse conference portfolio, our experienced team conducts extensive market research and targeted outreach. The results translate into innovative, high-quality conference events designed to exceed the dynamic informational needs of the healthcare community.
About Bayer Schering:
Bayer Schering Pharma is one of the 10 largest specialty pharmaceutical companies in the world. It markets products in more than 100 countries worldwide and in 2008 generated sales of over EUR 10.7 billion.
For further information please visit: http://www.bayerhealthcare.com/scripts/pages/en/index.php
SOURCE:
ExL Pharma
555 8th Ave Ste 310
New York NY USA 10018
http://www.exlpharma.com
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12-02-2009 : Top Turkish Transplant Hospital Begins Certification Training on Syncardia Total Artificial Heart
TOP TURKISH TRANSPLANT HOSPITAL BEGINS CERTIFICATION TRAINING
ON SYNCARDIA TOTAL ARTIFICIAL HEART
-- Ege University Performs 1,100 Open Heart Surgeries Annually
http://www.syncardia.com
Tucson AZ USA -- Medical Industry E-Mail News™ -- Dec 02 2009 -- On Nov. 30 and Dec. 1, the surgical team from Ege University in Izmir, Turkey, led by Prof. Mustafa Ozbaran, head of the Transplant and Assist Device Program, completed the first phase of certification training for the SynCardia temporary CardioWest™ Total Artificial Heart in Paris.
"We are excited to deliver this technology to our sickest patients who do not have any other chance to survive until a donor heart is available," said Prof. Ozbaran. "The SynCardia Total Artificial Heart is an important and complementary tool for our assist device program."
Ege University is one of the biggest and oldest universities in Turkey. The heart transplant program, started in 1998, has become the most active program in the country, performing a total of 130 transplants. Each year, Ege University performs approximately 1,100 open heart surgeries.
In Turkey, the average wait time for a donor heart transplant is 18 to 24 months. There are currently 43 patients on the waiting list for a donor heart. Ege University is the first transplant hospital in Turkey and the 46th in the world to begin certification training for the SynCardia Total Artificial Heart.
Originally used as a permanent replacement heart, the Total Artificial Heart is currently approved as a bridge to human heart transplant for patients dying from end-stage biventricular failure. The Total Artificial Heart is the only device that provides immediate, safe blood flow of up to 9.5 L/min through both ventricles.
The SynCardia Total Artificial Heart is the first and only FDA, Health Canada and CE Mark approved Total Artificial Heart in the world. There have been more than 800 implants of the Total Artificial Heart, accounting for more than 170 patient years of life on the device.
SOURCE:
SynCardia Systems Inc
http://www.syncardia.com
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11-20-2009 : TECHNOLOGY REMEDY FOR AILING HEALTHCARE SYSTEM
TECHNOLOGY REMEDY FOR AILING HEALTHCARE SYSTEM
IVANS' Survey Indicates Providers Will Make Better Use of Technology to Offset Changes to Healthcare
-- Leading IT company IVANS assists organizations with technological upgrades to keep up with healthcare reform
http://www.ivans.com/healthcare/providers
Stamford CT USA -- Medical Industry E-Mail News™ -- Nov 20 2009 -- A recent poll of healthcare providers indicates that as the country moves through healthcare reform and defining "meaningful use," providers plan to make better use of healthcare information technology when it comes to their everyday practices.
"More than 30% of those we surveyed indicated that they would make better use of technology to help offset the impact of proposed Medicare payment cuts on their business," said Clare DeNicola, CEO of IVANS. "Many of them are already tightening their belts because of the current economy. From their perspective, technology is not simply a way to cut costs but, more importantly, to increase efficiencies to maintain the quality of care to their patients."
IVANS, Inc, an information technology services company, asked healthcare providers to weigh in on issues tied to healthcare reform, including the role of technology in their practice, proposed Medicare cutbacks and what are they are doing to prepare themselves for potential changes. The web-based survey to which more than 200 providers responded was conducted in October 2009, following on the heels of the Congressional Budget Office's accounting of cost reductions contained within the U.S. Senate Finance Committee's proposed healthcare bill.
The healthcare reform bill recently passed by the House also has provisions that will cut Medicare funding substantially over the upcoming years. For the facilities and providers who focus on elder care, including the long-term and chronic care segment of the healthcare population, these cuts will have a deep and considerable impact on their business and the decisions they make when it comes to their patients.
Additional ways survey respondents said they would deal with payment cutbacks included the following:
One quarter said they will provide additional and new training for staff members
Another quarter said they would not do anything to prepare their practice/staff to offset cuts. While the reasons are not fully clear, it could be speculated that many providers are at an impasse when it comes to making changes to their day-to-day operations, as they cannot predict what the future holds.
THOMPSON REUTERS REPORT: WASTE IN US HEALTHCARE
A recent report by Thomson Reuters indicated that the US healthcare system wastes approximately $700 billion annually, pointing to administrative inefficiency and redundant paperwork for as much as 18% of this waste.
To this, DeNicola commented, "One prescription for our nation's healthcare deficit is the implementation of technology and making better use of what's presently available. By using information technology, or IT, providers can lower the cost and improve the quality of healthcare overall."
"Many facilities still operate with older technology infrastructures," she continued. "By upgrading these infrastructures and operating systems, they likely will experience immediate benefits, from faster claims processing and access to online applications such as patient insurance verification." Over time, DeNicola explained, these improvements also better position healthcare care facilities to add efficiencies, including e-prescribing, home monitoring and the exchange of important patient information.
A key player in helping providers comply with Medicare Contracting Reform, part of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, IVANS has been heavily involved in the modernization efforts of Medicare. To generate similar efficiencies across the healthcare industry as a whole, IVANS encourages healthcare providers to implement more current technologies now, such as high-speed networks, to support faster claims processing and information sharing in the near term, while preparing to handle the more data-intensive applications (such as electronic health records) that will be required in the future.
ABOUT IVANS:
Headquartered in Stamford, Connecticut, IVANS serves over 600 insurance and healthcare organizations, more than 30,000 independent insurance agents, and 135,000 healthcare providers. It provides insurance, healthcare, retail, manufacturing, and business services organizations with fully managed network, electronic data interchange (EDI) and agency-company interface solutions to help solve complex business issues. IVANS customers use these technologies everyday to increase sales, streamline operations, and improve customer service.
ABOUT THE SURVEY:
The survey is part of IVANS' continuing efforts to address the needs of healthcare providers nationwide and encourage a dialogue between professionals about how the current healthcare environment is impacting their daily business and what tools they can use to navigate the ever-changing system.
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11-18-2009 : BY RIDING WITH TEAM SYNCARDIA IN EL TOUR DE TUCSON
TOTAL ARTIFICIAL HEART RECIPIENT TO CELEBRATE 2ND ANNIVERSARY WITH DONOR HEART
BY RIDING WITH TEAM SYNCARDIA IN EL TOUR DE TUCSON
http://www.syncardia.com
-- 30-Year-Old Female Bridged-to-Transplant Thanksgiving 2007 Will Ride Alongside Cardiothoracic Surgeon Who Saved Her Life
Tucson AZ USA -- Medical Industry E-Mail News™ -- Nov 18 2009 -- On Nov. 21, 30-year-old Vanessa Cirillo will celebrate her second anniversary of being bridged to heart transplant with the SynCardia temporary CardioWest™ Total Artificial Heart by riding in the 2009 El Tour de Tucson cycling race. She will ride as a member of Team SynCardia, alongside the world-renowned cardiothoracic surgeon that saved her life, Dr. Jack Copeland.
"I think the bike race is a great way to celebrate my new beginning," said Cirillo. "You need to go through struggles and learn lessons to become a better person. Once you have that strength, you can give more to others. This race and helping raise awareness about organ donation allows me to do that."
Cirillo suffered a heart attack in 2000, which developed into cardiomyopathy over the next seven years. In August 2007, Cirillo's heart was no longer pumping enough blood to sustain her body. She was flown from a Las Vegas hospital to University Medical Center in Tucson, Arizona, and was implanted with the Total Artificial Heart the following day. She was transplanted 106 days later, two days after Thanksgiving.
After being discharged from the hospital with her new donor heart, Cirillo began volunteering with the Donor Network of Arizona. She, along with other transplant recipients and families of organ donors, provide information, answer questions and dispel myths about organ donation.
"Since I was little, I always knew I wanted to help people," said Cirillo. "My experience being bridged-to-transplant with the Total Artificial Heart has lit the path in front of me."
El Tour de Tucson will be Cirillo's first cycling race. Her parents, Barbara and Umberto, are traveling from their home in Florida to cheer her on. Her sister Erica, who lives in Tucson, plans to throw a "Team Vanessa" party before the race.
Cirillo will race alongside other members of Team SynCardia, including SynCardia co-founders, Dr. Copeland and Dr. Marvin Slepian, as well as fellow Total Artificial Heart recipient and transplant games gold medalist, Bill Wohl.
Originally used as a permanent replacement heart, the Total Artificial Heart is currently approved as a bridge to human heart transplant for patients dying from end-stage biventricular failure. The Total Artificial Heart is the only device that provides immediate, safe blood flow of up to 9.5 L/min through both ventricles. See Vanessa Cirillo boxing while on the Total Artificial Heart here.
The SynCardia Total Artificial Heart is the first and only FDA, Health Canada and CE Mark approved Total Artificial Heart in the world. There have been more than 800 implants of the Total Artificial Heart, accounting for more than 170 patient years of life on the device.
SOURCE:
SynCardia Systems Inc
http://www.syncardia.com
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11-16-2009 : EUROPLX ANNOUNCES PHARMA PARTNERING 2010 EVENTS
EUROPLX ANNOUNCES PHARMA PARTNERING 2010 EVENTS
http://www.europlx.com
Barcelona, Berlin & Malta to host pharmaceutical events
euroPLX 41 Barcelona attendance data also released
Barcelona Spain -- Medical Industry E-Mail News™ -- Nov 16 2009 -- More than 150 pharma and biotech industry delegates from 35 countries convened at euroPLX 41 Barcelona, in order to discuss and negotiate pharma deals, organizers announced today. Barcelona's leading pharma partnering event featured an average of 23 pre-scheduled one-on-one negotiations per participating company on two conference days.
Almost 30% of the participating companies were newcomers; i.e. they have never had a delegate at a euroPLX meeting before. Most of the newcomers were attracted to euroPLX by word of mouth.
For the organizers, this is a clear sign that euroPLX, which was founded in 1995 as the world's first no-lecture, no-presentation forum for pharma deals, continues to lead the way in pharma partnering.
The following 3 euroPLX events are confirmed for 2010:
With an already rapidly growing registration list, euroPLX 42 Valletta (Malta) will be the first euroPLX event in 2010. It will be held in the Hilton Malta, in the Portomaso marina area of St. Julians, just north of Valletta, on March 1-2 2010.
For the first time in Berlin Germany, euroPLX 43 Berlin will be held on June 14-15 2010, in the Ellington Hotel, which is located right in the centre of Berlin, with many famous places in walking distance. Diner sponsors for this event will be Dr. Kade Pharmazeutische Fabrik GmbH and Berlin-Chemie AG, a subsidiary of Menarini.
As Barcelona's premier pharma partnering event, euroPLX 44 Barcelona will be held on Nov 8-9 2010, in the Hilton Diagonal Mar, Barcelona Spain.
For more details, please visit: http://www.europlx.com
About Raucon & euroPLX:
euroPLX® (short for European Pharma License Exchange) is a brainchild and Europe registered trademark of RauCon. As a specialist consultancy for providing and organizing collaborative opportunities, RauCon caters to international pharma and biopharma business development and licensing executives, with organizational tools for the optimization of the business development process, advice, and career support.
Having organized partnering events in Europe, North America, and Australia since 1987, RauCon has pioneered the Pharma License Exchange concept in 1995, a novel business development platform for the pharmaceutical industry. Since then each single euroPLX Meeting was meticulously planned and prepared by Dr. Norbert Rau and Mrs. Anke Rau who have an up-to-date perspective on the industry since more than two decades.
SOURCE:
RauCon Business Development
Kurfurstenstrasse 1A
Dielheim 69234 Germany
http://www.europlx.com
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11-12-2009 : DIA (Drug Information Association) 46th Annual Meeting
FDA Commissioner Margaret Hamburg to Deliver Keynote Address at
DIA (Drug Information Association) 46th Annual Meeting
June 13-17 2010 -- Washington DC
http://www.diahome.org/diahome/FlagshipMeetings/home.aspx?meetingid=20751
Horsham PA USA -- Medical Industry E-Mail News™ -- Nov 12 2009 -- Dr. Margaret Hamburg, Commissioner of the US Food & Drug Administration (FDA), will deliver the opening keynote address to more than 8,000 professionals from the biopharmaceutical and related sectors at the Drug Information Association (DIA) 46th Annual Meeting.
The DIA 46th Annual Meeting will take place June 13-17 2010, in Washington DC. The DIA Annual Meeting is the premier event to attend each year by professionals from the biopharmaceutical and related sectors, as well as regulatory professionals from around the world. There is no other event of its kind that can rival the breadth and depth of experience that this meeting delivers. With 25 content areas and 350 sessions, the presentations are geared to all experience levels and functional areas.
"Dr. Hamburg is an inspiring public health leader with broad experience in public health and medicine, infectious disease, bioterrorism and emergency preparedness," says DIA Worldwide Executive Director Paul Pomerantz. "We are delighted to have her open our 46th Annual Meeting in Washington DC -- home of FDA and the global center of public health policy."
Dr. Margaret Hamburg was nominated by President Barack Obama for the FDA Commissioner on March 25, 2009 and on May 18 2009, became the 21st Food & Drug Commissioner. She previously served as the assistant secretary for planning and evaluation in the U.S. Department of Health & Human Services under President Clinton, and as the assistant director of the National Institute of Allergy and Infectious Diseases of the National Institutes of Health.
In 2001, Dr. Hamburg became Vice President for Biological Programs at the Nuclear Threat Initiative, a foundation dedicated to reducing the threat to public safety from nuclear, chemical, and biological weapons. In that position, she advocated for broad reforms in public health infrastructure and policy, from local health departments to the national agency, in order to meet the dangers of modern bioterrorism as well as the threats of naturally occurring infectious diseases such as pandemic flu. Dr. Hamburg is only the second woman to serve as FDA commissioner in the agency's 100-year history.
Register Here for the 46th Annual Meeting:
About the Drug Information Association (DIA)
A nonprofit, neutral, multidisciplinary, global, member-driven association, DIA serves more than 30,000 professionals in the biopharmaceutical industry, academia, research organizations and governmental bodies worldwide. Through its domestic and international meetings, training courses, workshops and webinars, DIA provides a neutral global forum for the exchange of information critical to the advancement of drug development and medical product lifecycle management. DIA is led by its volunteer Board of Directors and executive management team and has headquarters in Horsham, PA USA, and offices in Basel Switzerland, Tokyo Japan, Mumbai India, and Beijing China. For more information, visit http://www.diahome.org or call 215-442-6100.
SOURCE:
Drug Information Association
800 Enterprise Rd Ste 200
Horsham PA USA 19044
http://www.diahome.org
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11-11-2009 : EUROPLX ANNOUNCES PHARMA PARTNERING 2010 EVENTS
Biomedical Market Newsletter® Press Release:
EUROPLX ANNOUNCES PHARMA PARTNERING 2010 EVENTS
http://www.europlx.com
Barcelona, Berlin & Malta to host pharmaceutical events
euroPLX 41 Barcelona attendance data also released
Barcelona Spain -- Medical Industry E-Mail News™ -- Nov 11 2009 -- More than 150 pharma and biotech industry delegates from 35 countries convened at euroPLX 41 Barcelona, in order to discuss and negotiate pharma deals, organizers announced today. Barcelona's leading pharma partnering event featured an average of 23 pre-scheduled one-on-one negotiations per participating company on two conference days.
Almost 30% of the participating companies were newcomers; i.e. they have never had a delegate at a euroPLX meeting before. Most of the newcomers were attracted to euroPLX by word of mouth.
For the organizers, this is a clear sign that euroPLX, which was founded in 1995 as the world's first no-lecture, no-presentation forum for pharma deals, continues to lead the way in pharma partnering.
The following 3 euroPLX events are confirmed for 2010:
With an already rapidly growing registration list, euroPLX 42 Valletta (Malta) will be the first euroPLX event in 2010. It will be held in the Hilton Malta, in the Portomaso marina area of St. Julians, just north of Valletta, on March 1-2 2010.
For the first time in Berlin Germany, euroPLX 43 Berlin will be held on June 14-15 2010, in the Ellington Hotel, which is located right in the centre of Berlin, with many famous places in walking distance. Diner sponsors for this event will be Dr. Kade Pharmazeutische Fabrik GmbH and Berlin-Chemie AG, a subsidiary of Menarini.
As Barcelona's premier pharma partnering event, euroPLX 44 Barcelona will be held on Nov 8-9 2010, in the Hilton Diagonal Mar, Barcelona Spain.
For more details, please visit: http://www.europlx.com
About Raucon & euroPLX:
euroPLX® (short for European Pharma License Exchange) is a brainchild and Europe registered trademark of RauCon. As a specialist consultancy for providing and organizing collaborative opportunities, RauCon caters to international pharma and biopharma business development and licensing executives, with organizational tools for the optimization of the business development process, advice, and career support.
Having organized partnering events in Europe, North America, and Australia since 1987, RauCon has pioneered the Pharma License Exchange concept in 1995, a novel business development platform for the pharmaceutical industry. Since then each single euroPLX Meeting was meticulously planned and prepared by Dr. Norbert Rau and Mrs. Anke Rau who have an up-to-date perspective on the industry since more than two decades.
SOURCE:
Dr. Norbert Rau
RauCon Business Development
http://www.europlx.com
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11-10-2009 : Bioworld Today launches BIOWORLD INSIGHT
Biomedical Market Newsletter® Press Release:
Bioworld Today launches BIOWORLD INSIGHT
http://www.bioworld.com/bio-insight
Delivered every Monday morning to your inbox; review this product complimentary for 30 days
Behind-the-scenes analysis and commentary in biotech
Receive insight into which products are ahead or behind in a particular product spaces
Tap into potential impact of new & pending regulatory rules & ideas for generating capital funding
To receive your Complimentary 4-Issue Trial of BioWorld Insight, visit: http://www.bioworld.com/bio-insight
Atlanta GA USA -- Medical Industry E-Mail News™ -- Nov 10 2009 -- The publishers of BioWorld Today have announced the debut of a new weekly publication and a special introductory offer for new subscribers.
Published by the editors of BioWorld Today, BioWorld Insight provides behind-the-scenes analysis and commentary on the biotechnology marketplace every Monday morning. It delivers ideas and insights into niche markets, business challenges and potential solutions that constantly face both industry giants and brand new startups.
Inside each issue subscribers will find charts and graphs of the key biotech metrics that are available nowhere else:
Clinical trial updates separated by indication (cancer, diabetes, etc.)
Details of collaborations by biotech & pharma companies
Manufacturing agreements
Deal modifications
Public financings
Public offering performance by underwriters
FDA actions and much more
"Bioworld Insight analyzes critical components of the biotech industry, from insights into which products are ahead or behind in a particular product space, the potential impact of new and pending regulatory rules and ideas for generating capital funding that is the lifeblood of the industry," says Glen Harris, Managing Editor.
INFORMATION IS AVAILABLE ONLINE:
To view the table of contents, samples pages, and to obtain ordering information, please visit:
http://www.bioworld.com/bio-insight
For priority delivery, please call 404-262-5476 or 800-688-2421.
ABOUT BIOWORLD:
BioWorld, published by AHC Media LLC, is an internationally recognized information provider for executives, analysts and investors following the day-to-day developments in the biotech, pharmaceutical and medtech markets. Focusing on scientific business news and information, BioWorld's websites provide access to daily developments in these sectors, as well as 18 years' worth of archived data, trends and company information.
Key products include BioWorld Today -- the newspaper of record for the biotech industry; BioWorld Insight -- a weekly monitor of biotech's financial markets; BioWorld International -- focusing on life science developments in Europe; and Medical Device Daily -- delivering daily business intelligence for the medtech industry.
SOURCE:
BioWorld Today
3525 Piedmont Rd NE Bldg 6 Ste 400
Atlanta GA 30305-1515 USA
http://www.ahcmedia.com
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11-09-2009 : DIA (Drug Information Association) In Europe To Host 10th Conference On Electronic Document Management
DIA (Drug Information Association) In Europe To Host 10th Conference On Electronic Document Management
Dec 03-04 2009 -- Vienna, Austria
http://www.diahome.org
Basel Switzerland -- Medical Industry E-Mail News™ -- Nov 09 2009 -- Representatives from industry and regulatory agencies will answer vital regulatory and software questions at the 10th Conference on European Electronic Document Management (EDM) by the Drug Information Association (DIA) on Dec 03-04 2009 in Vienna Austria, organizers said today.
Background:
How happy are we with our EDM systems? Are we getting all the benefits out of our elaborate software packages? If not, what can we do to unleash the full power of these tools to serve end-to-end processes, in a highly regulated environment?
Session topics will include:
Operating & Implementing EDMS Technologies
Leveraging Technologies for Quality & Efficiency
Best Practices in Managing the Document Lifecycle
Using Metadata Standards in the Use & Reuse of Regulatory Information
XML Developments & XML Implementation
Electronic Archiving Strategies for Submission Documentation
Electronic Trial Master File Management
Preparing eCTD Filings for Different European Procedures
2009 into 2010 - Current Agency Experience & Requirements
Current & Future Submission Formats
A special Meet the Regulators session will allow attendees to ask questions of regulatory representatives, including:
Christa Wirthumer-Hoche, Head, Unit for Marketing Authorization & Life-cycle Management of Medical Products, AGES PharmMed, Austria
Timothy Buxton, Head of Sector, Project Management, EMEA, EUStan A. Van Belkum, Program Manager, Medicines Evaluation Board, The Netherlands
Gary Gensinger, Director, Regulatory Review Support Staff, CDER, FDA, USA
Stephan P. Jaermann, Business Project Manager, Swissmedic, Switzerland
Full-day pre-conference tutorials on December 2 include:
eSubmission - A Highlight of the Differences
eTMF - Migrating from Paper Trial Master Files to Electronic
A Document Management Practicum: Ideas to Improve & Enhance your Journey into the Future
Keynote Speaker:
Stan A. Van Belkum, Program Manager, Medicines Evaluation Board, The Netherlands, will deliver the keynote address.
"Many companies in the pharmaceutical industry now have well-established EDM and publishing systems and many more are gearing up to face new mandatory requirements for electronic Common Technical Document (eCTD) filing, says Program Co-Chair Melanie J. Clare, Global Head, Clinical Document Management & Publishing, GlaxoSmithKline, UK. "While the focus has been on preparation of eCTD filings over the past years the life-cycle management aspects and the accessibility of the information throughout the retention time will now receive attention."
Register for 10th Conference on European Electronic Document Management (EDM):
Who Should Attend:
Document & eRecords Managers
Standards Implementation Specialists & Associates
Quality Assurance & Compliance Professionals
Medical Writers
IT & Support Personnel
Contract Researchers & Service Support Providers
Academic Researchers
Regulatory Authority Representatives
Validation Professionals
Pharmacovigilance Professionals
Knowledge / IP Professionals
Metadata Specialists
Submissions Publishers
About the Drug Information Association (DIA)
The Drug Information Association (DIA) is a nonprofit, multidisciplinary, global association that serves more than 30,000 professionals in the biopharmaceutical and related industries worldwide. Through its domestic and international meetings, training courses, workshops and webinars, DIA provides a neutral forum for the exchange of information critical to the development and lifecycle management of biopharmaceutical and related products. Headquartered in Horsham, PA USA, and with offices in Basel Switzerland, Tokyo Japan, Mumbai India, and Beijing China, the Association is led by its volunteer-based board of directors and executive management team. For more information, visit http://www.diahome.org or call DIA in Europe at 011-41-61-225-51-51.
SOURCE:
DIA European Office
011-41-61-225-51-36
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11-05-2009 : FOR FREEDOM™ DISCHARGE DRIVER TO POWER SYNCARDIA TOTAL ARTIFICIAL HEART
INVESTIGATIONAL DEVICE EXEMPTION APPLICATION SUBMITTED TO FDA
FOR FREEDOM™ DISCHARGE DRIVER TO POWER SYNCARDIA TOTAL ARTIFICIAL HEART
http://www.syncardia.com
-- 1st U.S. Discharge Driver Designed to Free Stable Total Artificial Heart Patients from the Hospital
Tucson AZ USA -- Medical Industry E-Mail News™ -- Nov 05 2009 -- Today, SynCardia Systems, Inc., manufacturer of the SynCardia temporary CardioWest™ Total Artificial Heart, announced it has submitted an application to the FDA to conduct an Investigational Device Exemption (IDE) clinical study of the Freedom™ discharge driver, designed to power the Total Artificial Heart outside the hospital.
“Stable Total Artificial Heart patients in the U.S. are currently confined to the hospital by the large 'Big Blue' hospital driver that powers the heart,” said Rodger Ford, SynCardia President and CEO.
“The IDE submission includes a request to conduct the clinical study at 30 U.S. centers,” said Mary Pat Sloan, VP of Global Training and Customer Support. “While many of our trial sites have been identified, we will be following up with additional transplant centers that have expressed interest in participating in the Freedom driver study.”
Later this month, SynCardia will submit the Freedom driver design dossier to the Notified Body for examination for the CE Mark in Europe.
Originally used as a permanent replacement heart, the Total Artificial Heart is currently approved as a bridge to human heart transplant for patients dying from end-stage biventricular failure. The Total Artificial Heart is the only device that provides immediate, safe blood flow of up to 9.5 L/min through both ventricles.
The SynCardia Total Artificial Heart is the first and only FDA, Health Canada and CE Mark approved Total Artificial Heart in the world. There have been more than 800 implants of the Total Artificial Heart, accounting for more than 170 patient years of life on the device.
- - - --
SOURCE:
SynCardia Systems Inc
1992 E Silverlake Rd
Tucson AZ USA 85713
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11-04-2009 : PERFORMED AT CLEVELAND CLINIC
WORLD'S 1ST TOTAL ARTIFICIAL HEART TO DUAL HEART & LIVER TRANSPLANT
PERFORMED AT CLEVELAND CLINIC
http://www.syncardia.com
-- 63-Year-Old Dentist Undergoes 14-Hour Landmark Surgery
Tucson AZ USA -- Medical Industry E-Mail News™ -- Nov 04 2009 -- On Nov. 3, 2009, SynCardia Systems, Inc., manufacturer of the SynCardia temporary CardioWest™ Total Artificial Heart, announced that Cleveland Clinic has performed the world's first Total Artificial Heart to dual heart and liver transplant.
"Cleveland Clinic has made medical history with their use of the Total Artificial Heart to bridge a very ill patient to a dual heart and liver transplant," said Dr. Jack Copeland, internationally renowned transplant surgeon and Total Artificial Heart pioneer. "My congratulations go out to Drs. Nicholas Smedira and Randall Starling, two world class physicians."
After living with the Total Artificial Heart for 113 days, on May 1, 2009, Dr. Michael Zabell received the donor heart and liver during a 14-hour landmark surgery involving two different transplant teams. Today, Dr. Zabell is enjoying life at home with his wife of 19 years and his two daughters, ages 17 and 15.
"I've had more doctors than the Cleveland Browns have had quarterbacks," said Dr. Zabell. "Dr. Smedira is not only an outstanding surgeon but he's really a wonderful guy. Cleveland Clinic has an outstanding group of surgeons, physicians and hospital staff, including my cardiologist Dr. Starling. I can't say enough about the care."
Dr. Zabell was first admitted to the hospital to wait for a heart transplant on Aug. 18, 2008. He was given medication to help his heart function, but his condition continued to deteriorate. By Jan. 8, 2009, his heart had become so weak that doctors needed to implant the Total Artificial Heart to buy him more time until a matching donor heart and liver could be found.
*Disclosure* Nicholas Smedira, MD, is a paid consultant for SynCardia Systems, Inc.
Originally used as a permanent replacement heart, the Total Artificial Heart is currently approved as a bridge to human heart transplant for patients dying from end-stage biventricular failure. The Total Artificial Heart is the only device that provides immediate, safe blood flow of up to 9.5 L/min through both ventricles.
The SynCardia Total Artificial Heart is the first and only FDA, Health Canada and CE Mark approved Total Artificial Heart in the world. There have been more than 800 implants of the Total Artificial Heart, accounting for more than 170 patient years of life on the device.
- - - --
SOURCE:
SynCardia Systems Inc
http://www.syncardia.com
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11-03-2009 : DIAGNOSIS & TREATMENT OF COMBAT BRAIN INJURIES
NEURO KINETICS & MILITARY RESEARCHERS IN PUSH TO IMPROVE
DIAGNOSIS & TREATMENT OF COMBAT BRAIN INJURIES
http://www.neuro-kinetics.com
T.R.U.E. Research Foundation Supports I-Portal® NOTC-Based mTBI Study at Military Medical Centers
20% of Soldiers Returning from Afghanistan & Iraq Suffer from mTBI (Mild Traumatic Brain Injuries)
Pittsburgh PA USA -- Medical Industry E-Mail News™ -- Nov 03 2009 -- With financial backing from a leading nonprofit supporter of military medical research, medical device manufacturer Neuro Kinetics, Inc. (www.neuro-kinetics.com) said today it is collaborating with the U.S. Army Aeromedical Research Laboratory (USAARL) at Fort Rucker, Alabama, and three other military medical facilities, in a comprehensive research project to improve early diagnosis and treatment of mild traumatic brain injuries (mTBI).
The coordinated research focuses on using Neuro Kinetics' I-Portal® NOTC (Neuro-Otologic Test Center) system to evaluate and characterize vestibular, auditory and oculomotor conditions in soldiers suffering from hard-to-detect mTBI as a result of blast exposure. An estimated 20% of soldiers returning from Afghanistan and Iraq suffer from mTBI.
The other military medical facilities in the research project are Tripler Army Medical Center (Hawaii), the Traumatic Brain Injury Warrior Resilience and Recovery Center at Fort Campbell (Kentucky) and Walter Reed Army Medical Center (D.C.).
The military researchers' purchase of NKI's I-Portal NOTC system was supported in part by grants from the T.R.U.E. Research Foundation (www.trueresearch.org) a 501(3) nonprofit corporation that assists the military medical community.
The project is expected to run until July 2010.
"It is our honor to be working closely with military researchers on this critically important effort," said J. Howison Schroeder, NKI President and CEO. "Research suggests that the oculometric measurements included in the I-Portal NOTC's battery of tests can provide effective neurophysiologic and vestibular-auditory evaluations for mTBI, and that in turn can improve early screening and treatment.
"Our wounded soldiers deserve the best care possible and we are proud to be playing our part to deliver exactly that," said Schroeder.
The NKI-military collaboration comes as a number of U.S. military facilities have installed the I-Portal NOTC system to improve diagnosis and monitoring of returning brain-injured military personnel. Numerous other federal government medical facilities, including those operated by the Veterans Administration and the US National Institutes of Health, also rely on NKI equipment for conducting daily clinical evaluations of patients, as well as undertaking a wide range of research projects.
ABOUT NEURO KINETICS, INC.
Neuro Kinetics, Inc. (www.neuro-kinetics.com) is a fast-growing manufacturer of noninvasive medical test equipment used worldwide by audiologists, neurologists, neuro-otologists, ophthalmologists, otolaryngologists and other medical specialists in the detection and evaluation of neurological, otological and vestibular disorders. The privately-owned company, originating in the 1970s, pioneered the development of vestibular and neuro-otologic testing equipment, including the renowned Barany (rotational) chair. The company's patented products include the I-Portal® NOTC (Neuro-Otologic Test Center) system, I-Portal® VNG (Video Nystagmography) system and I-Portal® VOG (Video Oculography) system, along with related accessories, software, training and support services. Users include doctors and researchers in universities and government facilities as well as specialists in fields such as audiology, neurology, neuro-otology, ophthalmology and otolaryngology.
SOURCE:
Neuro Kinetics, Inc.
128 Gamma Dr
Pittsburgh PA USA 15238
http://www.neuro-kinetics.com
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10-29-2009 : New Study Finds the Availability of Chiropractic Physician Services Improves the Value of Health Benefit Plans
New Study Finds the Availability of Chiropractic Physician Services Improves the Value of Health Benefit Plans
http://www.foundation4cp.com
-- To download the full report, click here:
Carmichael CA USA -- Medical Industry E-Mail News™ -- Oct 29 2009 -- A new report, prepared by a global leader for trusted human resources and related financial advice, products and services, finds that the addition of chiropractic care for the treatment of low back and neck pain will likely increase value-for-dollar in US employer-sponsored health benefit plans.
Authored by Niteesh Choudhry, MD, PhD, and Arnold Milstein, MD, the report can be fully downloaded at: Full Report
http://images.vortala.com/chiropractor/USA/California/Carmichael/Foundation%20for%20Chiropractic%20Progress/SiteGraphics/ChiropracticServicesReport.pdf
Executive Summary:
Low back and neck pain are extremely common conditions that consume large amounts of health care resources. Chiropractic care, including spinal manipulation and mobilization, are used by almost half of US patients with persistent back-pain seeking out this modality of treatment.
The peer-reviewed scientific literature evaluating the effectiveness of US chiropractic treatment for patients with back and neck pain suggests that these treatments are at least as effective as other widely used treatments. However, US cost-effectiveness studies have methodological limitations.
High quality randomized cost-effectiveness studies have to date only been performed in the EU. To model the EU study findings for US populations, researchers applied US insurer-payable unit price data from a large database of employer-sponsored health plans. The findings rest on the assumption that the relative difference in the cost-effectiveness of low back and neck pain treatment with and without chiropractic services are similar in the US and the EU.
The results of the researchers' analysis are as follows:
Effectiveness: Chiropractic care is more effective than other modalities for treating low back and neck pain.
Total cost of care per year:
-- For low back pain, chiropractic physician care increases total annual per patient spending by $75 compared to medical physician care.
-- For neck pain, chiropractic physician care reduces total annual per patient spending by $302 compared to medical physician care.
Cost-effectiveness: When considering effectiveness and cost together, chiropractic physician care for low back and neck pain is highly cost-effective, represents a good value in comparison to medical physician care and to widely accepted cost-effectiveness thresholds.
These findings, in combination with existing US studies published in peer-reviewed scientific journals, suggest that chiropractic care for the treatment of low back and neck pain is likely to achieve equal or better health outcomes at a cost that compares very favorable to most therapies that are routinely covered in US health benefits plans. As a result, the addition of chiropractic coverage for the treatment of low back and neck pain at prices typically payable in US employer-sponsored health benefit plans will likely increase value-for-dollar by improving clinical outcomes and either reducing total spending (neck pain) or increasing total spending (low back pain) by a smaller percentage than clinical outcomes improve.
Accordingly, this report was commissioned by the Foundation for Chiropractic Progress to summarize the existing economic studies of chiropractic care published in peer-reviewed scientific literature, and to use the most robust of these studies to estimate the cost-effectiveness of providing chiropractic insurance coverage in the US.
Gerard Clum, DC, spokesperson for the Foundation for Chiropractic Progress and president of Life Chiropractic College West, says, "While some studies reflect cost efficiencies and others clinical efficiencies, these findings strongly support both for chiropractic care of neck pain and low back pain."
About F4CP:
A not-for-profit organization, the Foundation for Chiropractic Progress (F4CP) embraces a singular mission to promote positive press for the profession in national, regional and local media. Through effective and ongoing initiatives, the Foundation's goal is to raise awareness to the many benefits provided by doctors of chiropractic. The F4CP relies upon strategic marketing campaigns that span prominent spokespersons, monthly press releases, public service announcements, and advertisements in high-profile media outlets.
To learn more about the Foundation, please visit us on the web at http://www.foundation4cp.com or call 866-901-f4cp.
SOURCE:
Foundation for Chiropractic Progress
http://www.foundation4cp.com
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10-28-2009 : Rennes University Hospital Begins SynCardia Certification Training For The Total Artificial Heart
Rennes University Hospital Begins SynCardia Certification Training For The Total Artificial Heart
http://www.syncardia.com
-- French Hospital Performs up to 1,400 Open Heart Surgeries Annually
Tucson AZ USA -- Medical Industry E-Mail News™ -- Oct 28 2009 -- On Oct. 26 & 27, the surgical team from Rennes University Hospital, led by Dr. Erwan Flecher and Prof. Jean-Philippe Verhoye, completed the first phase of certification training for the SynCardia temporary CardioWest™ Total Artificial Heart in Paris. The team trained exclusively with the new Companion Driver System, which received the CE Mark to power the Total Artificial Heart in Europe on October 13, 2009.
"We perform anywhere from 1,200 to 1,400 open heart surgeries annually," said Dr. Flecher, who was first introduced to the Total Artificial Heart as a resident at La Pitie in 1999. "It is critical for us to have this life-saving technology to save our sickest patients. We look forward to Phase 3 of certification training, our proctored first implant of the Total Artificial Heart using the new Companion Driver System."
The Companion Driver System represents the next generation in pneumatic driver technology. The user-friendly touch screen display provides access to all driver functions and modes, no keyboard required. To make it simpler for hospitals and patients, the Companion Driver is serviced by replacement. No onsite repair, service or inventory of parts is required. Drivers are delivered and returned via express delivery service.
Rennes University Hospital has six cardiac care operating rooms. In 2007, the hospital performed 22 heart transplants. Rennes University Hospital is the 45th hospital in the world and the 26th in Europe to complete the first phase of certification training to become a SynCardia Certified Center.
Originally used as a permanent replacement heart, the Total Artificial Heart is currently approved as a bridge to human heart transplant for patients dying from end-stage biventricular failure. The Total Artificial Heart is the only device that provides immediate, safe blood flow of up to 9.5 L/min through both ventricles.
The SynCardia Total Artificial Heart is the first and only FDA, Health Canada and CE Mark approved Total Artificial Heart in the world. There have been more than 800 implants of the Total Artificial Heart, accounting for more than 170 patient years of life on the device.
SOURCE:
SynCardia Systems Inc
http://www.syncardia.com
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10-26-2009 : Find Out How 3 Leading Health Plans Are Managing Specialty Drugs Across The Pharmacy & Medical Benefit
Find Out How 3 Leading Health Plans Are Managing Specialty Drugs Across The Pharmacy & Medical Benefit
-- Atlantic Information Services Audioconference to Present Strategies on how to Manage Specialty Drugs in the Medical Benefit, Nov 3 2009
http://www.AISHealth.com/Products/C9P26_110309EBBM.html
Washington DC USA -- Medical Industry E-Mail News™ -- Oct 26 2009 -- Atlantic Information Services, Inc. (AIS), publisher of Specialty Pharmacy News, announced details today of its November 3 2009 Audioconference on How To Manage Specialty Drugs in the Medical Benefit.
Register for AIS's Nov. 3 audioconference, Strategies to Manage Specialty Drugs in the Medical Benefit:
BACKGROUND:
Data show that as much as 70% of a health plan's spend on specialty medications may fall under the medical benefit. But a recent study of 69 health plans revealed that only one-third of respondents knew what they spent on specialty drugs under the medical benefit. It's now more important than ever for plans to have greater scrutiny of how their health care dollars are being spent, especially on the medical side -- a task that's much easier said than done.
Find out how three leading health plans have begun to manage specialty drugs in both the pharmacy and the medical benefit, and what results they are achieving so far.
Many specialty therapies are reimbursed under the medical benefit. But with physicians buying and billing drugs they administer in their offices and using ambiguous billing codes, it can be extremely difficult to manage these therapies. With patients and payers equally at risk when the complete pharmacological picture is unknown, health plans need to gain control of their spending on specialty pharmaceuticals under the medical benefit -- as soon as possible.
SPEAKERS:
Dial in on Nov. 3 to hear three industry experts -- Donna Paine, Pharm.D., from Blue Cross Blue Shield of Rhode Island, Ken Schaecher, M.D., from SelectHealth, and Lynn Nishida from RegenceRx -- discuss the details of their own experiences in managing specialty drugs on both the pharmacy and, more importantly, the medical side.
FIND OUT THE ANSWERS TO KEY QUESTIONS SUCH AS:
How do the big challenges with traditional pharmacy and medical benefit designs influence prescribing of high-cost oral and injectable medications?
What are the major advantages of managing drugs on both the pharmacy and medical benefits? What are the major disadvantages?
What were the implementation processes for the companies?
How were the programs designed? What were their goals?
Which strategies employed worked most effectively? Which were not successful?
What outcomes did the companies experience?
What are some of the issues that still remain?
After a 60-minute presentation, you'll have an opportunity to interact with the speakers during a 30-minute Q&A period.
REGISTRATION INFORMATION:
Four Easy Ways to Register for the Nov. 3 audioconference:
Strategies to Manage Specialty Drugs in the Medical Benefit
1. Visit http://www.aishealth.com/Products/C9P26_110309EBBM.html
2. Call 800-521-4323 (Please reference conference code EBBM)
3. Fax your registration to 202-331-9542 (Please reference conference code EBBM)
4. Mail your registration payable to Atlantic Information Services, to:
Atlantic Information Services (EBBM)
1100 17th St NW Ste 300
Washington DC 20036
PRICING:
All formats come with written materials as a PDF:
-- $299 Audioconference
(Regularly $329 -- save $30)
-- $391 Audioconference & CD (of the full audioconference)
(Regularly $421 -- save $30)
-- $391 Audioconference & MP3 file (of the full audioconference)
(Regularly $421 -- save $30)
Can't make it on November 3?
-- $299 CD
(Regularly $329 -- save $30)
-- $299 MP3 file
(Regularly $329 -- save $30)
SOURCE:
Atlantic Information Services, Inc.
1100 17th St NW Ste 300
Washington DC USA 20036
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10-24-2009 : Cooperative Diagnostics Launches New Diagnostic Test for Chronic Fatigue Syndrome Associated Virus
Cooperative Diagnostics Launches New Diagnostic Test for Chronic Fatigue Syndrome Associated Virus
http://www.codiagnostics.com/XMRV/index.php
Greenwood SC USA -- Medical Industry E-Mail News™ -- Oct 24 2009 -- Cooperative Diagnostics, LLC announced today the availability of a new diagnostic assay for Xenotropic Murine Leukemia-Related Virus (XMRV) to assist physicians in the diagnosis of chronic fatigue syndrome and other disorders potentially caused by the virus. Testing services will also be made available to the general public.
The Simplex XMRV test identifies patients infected with XMRV. XMRV has been recently identified in 95% of chronic fatigue syndrome patients, in addition to large numbers of patients with Fibromyalgia, Atypical Multiple Sclerosis, and other clinical conditions. Cooperative Diagnostic's XMRV assay is the first diagnostic for the virus to be made available to the public.
"This may well be the fulfillment of a promise that I made a number of years ago to two good friends, who both became ill from chronic fatigue syndrome. I saw firsthand the mental anguish they endured by those closest to them including the medical community as they were told their condition could be psychological," said Brent C. Satterfield, Ph.D., President and CEO of Cooperative Diagnostics, LLC. "When we learned that XMRV might have such a high association with chronic fatigue syndrome, we immediately became interested in developing a test. Now, my two friends and everyone else who has suffered from the condition can take testing for XMRV into their own hands."
The Cooperative Diagnostics XMRV test is based on its proprietary real-time PCR nucleic acid detection technologies. It is capable of detecting the virus inside of blood cells. The test is available to the public at http://www.codiagnostics.com/XMRV/index.php for $399. In order to provide quality testing in a high throughput environment, Cooperative Diagnostics has contracted Clinical Reference Laboratory, Inc. (CRL), to process these assays.
CRL's Executive Director of Molecular Diagnostics, Dr. Heather Newkirk, said "this unique technology from Cooperative Diagnostics enables a powerful detection product which synergizes well with CRL's expertise in offering quality molecular services. We look forward to working with Cooperative Diagnostics to provide quality services."
About Cooperative Diagnostics, LLC:
Cooperative Diagnostics, founded in January 2008, brings the most advanced molecular diagnostics to the people and nations that need them most.
For more information visit: http://www.codiagnostics.com
About Clinical Reference Laboratory, Inc:
Established in 1979, CRL is a privately-held reference laboratory in Lenexa, Kansas offering leading-edge testing services in the areas of clinical trials, molecular diagnostics, insurance, and toxicology. CRL is one of the largest single sight laboratories in the country and analyzes over 18 million tests annually.
Additional Information is available at: http://www.crlcorp.com
SOURCE:
Cooperative Diagnostics LLC
http://www.codiagnostics.com
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10-23-2009 : MEDICAL DEVICE COMPANY PARTNERSHIP WITH THE UNIVERSITY OF MEMPHIS ANNOUNCED
MEDICAL DEVICE COMPANY PARTNERSHIP WITH THE UNIVERSITY OF MEMPHIS ANNOUNCED
Plan To Recruit Employee-Students By Providing A Full-Tuition Paid MBA
Program Includes: Stipend, Internship & Offer Of Employment Through The Customer-Driven MBA Program
Students Can Apply Through December 2009 For The 2010 Program
http://www.memphis.edu/fcbe/cdmba_apply.php
Memphis TN USA -- Medical Industry E-Mail News™ -- Oct 23 2009 -- University of Memphis Fogelman College officials are providing a program that is specifically focused on the medical device manufacturing industry. Students who complete the program will be offered employment with sponsoring medical device companies at competitive salaries.
As top medical device companies are demanding more from their new employees, the firms are trying something different to recruit newcomers. Companies are now partnering with the University of Memphis to provide student recruits with a full-tuition-paid global MBA that encompasses a direct industry tract in the biomedical field.
Training for Managers at Mid-Level & Above:
The MBA program at the University of Memphis will focus on recruiting, educating and training managers at mid-level and above in globalized general business and specific medical industry subjects.
"Medical device companies require a skill set and knowledge-base from their employees that are very specific to the industry. It is essential for medical professionals to understand the regulatory pathway, product development cycles, and Medicare reimbursement, for example," says Barbara DeVivo, the MBA Marketing Director at the University of Memphis Fogelman College who has spent her career as a marketer in the medical device industry. "These topics are never taught in graduate school. The knowledge is acquired through years of exposure in the industry," DeVivo says.
Program Details:
The customer-driven MBA will provide prospective student-employees with an avenue to engage in a rigorous 21-month full-time, work-study MBA program, where they will learn core business subjects, industry specific knowledge, and corporate management through internships throughout the program.
In addition to these skills, the program will train students with the fundamentals in:
Governance & ethics
Emotional intelligence
Teamwork
Leadership
Critical thinking
Creativity
Innovation
Problem-solving
Part-Time Internships with Medical Device Companies:
A key component of the 21-month program will be part-time internships with the sponsoring medical device companies during the main academic years, September to May, and full-time during the summer. Additionally, students who successfully complete the program will be offered employment with their sponsoring companies at competitive salaries.
Plans call for the collaborating companies to support the program financially. Students will each receive tuition payment, plus a $36,000 stipend, for the duration of their enrollment.
Upon graduation, the MBA degree-holders will not only have broad and specific knowledge of business concepts, but will be familiar with the operations of their hiring companies. Thus, they can be even more valuable to the companies, and the companies will see a quicker return on their investments in the students.
History of Program Launch:
Dr. Rajiv Grover unveiled the new program at the Fogelman College of Business & Economics kickoff luncheon in May 2008. Dr. Grover, Dean of the Fogelman College, calls it "customer driven," because it will help answer a need for managers in local companies who are educated in the classic curriculum of an MBA program, as well as in certain disciplines that are particularly needed by those companies.
Recruitment:
Students will be recruited locally, nationally and internationally. The companies will be involved in selecting the students for acceptance into the program.
"Workforce development is a key concern of local business leaders, Grover said, and this program will address that concern. It will bring well-qualified employees into the local business community, and allow the companies and university to educate them witht he right industry training, so they can be effective Day 1 postgraduation," says Dr. Grover.
Embedded Knowledge:
"Knowledge of a company is what we call embedded knowledge," Grover explained. "It is the sort of thing that takes time for a new employee to learn. Graduates of this MBA program will go to work having that knowledge from their first day on the job. That will enable them to begin making significant contributions to their companies more quickly."
Customized Courses:
The biomedical track will offer four customized courses that have been developed with the help of top professionals in the medical device industry. These courses include health care economics, buyer (e.g.,hospitals, surgeons) behavior, global supply chain management in the biomedical field, and new product development.
Additionally, the new program will call on the expertise of faculty members from throughout the University, and classes will also be co-taught by leading professionals in the community.
Dr. Grover characterizes the program as a "win-win-win" situation. "The University will get very good students. The students will get a very good education and on-the-job work experience virtually at no cost, in addition to a $36,000 stipend. The businesses involved will then get excellent workers who can make significant contributions to the company immediately."
Reviewing Candidates:
The University of Memphis Fogelman College of Business and its Biomedical Corporate Partners are currently reviewing candidates through December 2009 for the Fall 2010 entering class. An initial enrollment of about 10 students in the biomed track is expected. That number should increase as the program gains prominence and knowledge of its existence spreads.
"We have been positively overwhelmed with the number of inquires coming in from interested students around the globe.The caliber of individuals that we are attracting is astonishing," says DeVivo. "We at the University look forward to placing these professionals with our Medical Device Corporate Sponsors much sooner than originally anticipated."
More Information Available at the University of Memphis Website:
http://www.customerdrivenmba.memphis.edu
To Apply:
To be considered for the program, please apply online below:
http://www.memphis.edu/fcbe/cdmba_apply.php
SOURCE:
Fogelman College of Business & Economics
http://www.customerdrivenmba.memphis.edu
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10-22-2009 : THEIR PRACTICES WITHIN WEEKS, DESPITE THE RECESSION
NEW COSMETIC DENTISTRY PROGRAM TO HELP DENTISTS TRANSFORM
THEIR PRACTICES WITHIN WEEKS, DESPITE THE RECESSION
http://www.healthcaresuccess.com/dental/cosmetics.html
Mentor OH USA -- Medical Industry E-Mail News™ -- Oct 22 2009 -- Harvey N. Silverman, DMD, founder of the Silverman Institute of Cosmetic Dentistry, has introduced a comprehensive "3-leg" program designed to help dentists achieve record levels of cosmetic dentistry, even while the recession drags on.
According to Silverman, "While 65% of dentists say they would like to see more cosmetic cases,* the reality is that even in the best of times most dentists do very little cosmetic dentistry at all. I therefore created the LifeLike Dentistry Program™ based on techniques I have seen and developed over the past 30 years to help dentists literally transform their practices within days."
Silverman advises that creating a truly cosmetic dentistry practice is virtually impossible unless the dentist is truly committed to doing more cosmetic dentistry, and then follows a well-designed system.
"There are three legs critical to doing more cosmetic dentistry. First you need the proper dental marketing strategies (both internal and external) to get patients to ask for -- and pay for -- cosmetic dentistry. Then you need advanced, simplified, clinical techniques to reduce the time and cost of cosmetic dentistry procedures, so that the patients will be able to afford it. Finally, you need special cosmetic dentistry management systems to tie everything together."
Steve Lehman, DDS, an early participant in the program reports, "We grossed almost $40,000 in new cosmetic cases the first month following Dr. Silverman's visit. In fact, in the first week I completed more cosmetic dentistry than I had in the previous six months."
Dr. Lehman admits he was skeptical prior to Dr. Silverman's visit. After all, like many dentists his practice was suffering from the effects of the recession, and he is absolutely uncomfortable with "selling" dentistry.
"You know, our practice is located in Fullerton CA, not Beverly Hills CA. Our patients are just everyday folks, and I am a low-key guy who has seen it all. Yet, Dr. Silverman showed me secrets to get my patients excited about the possibilities of a more attractive smile, and then showed me how to make the dentistry affordable through clinical and management improvements.
"Now we can give patients the beautiful smile they want," continues Lehman, "in a single office visit, without the pain, without "selling" and at half the cost because everything is done right in my office."
Silverman's LifeLike Dentistry Program™ includes extensive pre-visit preparation, a two-day on-site training with both doctors and staff, hands-on clinical training, daily access to Dr. Silverman through both phone and email, daily reports, weekly reviews, an on-site follow up visit and ongoing marketing and management support.
As an additional benefit of this system, Silverman has teamed with Healthcare Success Strategies, a leading dental marketing firm, to provide participating dentists with access to custom marketing materials and programs that can be used both internally and externally to build patient inquiries.
Taken together, the LifeLike Dentistry Program™ offers dentists a complete turnkey program that can begin generating new income from day one.
Dentists interested in learning more are encouraged to call Healthcare Success Strategies at 888-679-0050 ext 4, or email lonnie@healthcaresuccess.com for complete details. More details about this program can also be found on the Healthcare Success Strategies' cosmetic dentistry marketing web page:
http://www.healthcaresuccess.com/dental/cosmetics.html
* The State of Dental Marketing, Dental Economics, Sept 2008, Stewart Gandolf and Lonnie Hirsch.
About Harvey Silverman, DMD:
Dr. Silverman is the founder of the Silverman Institute of Cosmetic Dentistry, which provides marketing, management, hands-on technical, online as well as telephonic support for dentists who want to spend up to 70% of their time practicing cosmetic dentistry. Over the past 20 years Dr. Silverman has converted numerous general practices into cosmetic dentistry practices, refined many of the original tooth bonding systems, introduced dental spas to the dental profession, created extreme makeovers, and refined the original porcelain veneers. He also invented and patented many of over the counter tooth whitening products.
About Health Care Success Strategies:
In their 35 years combined experience, founding partners Lonnie Hirsch and Stewart Gandolf have spoken to tens of thousands of private practitioners and healthcare professionals across North America, and have privately consulted and created successful marketing campaigns for more than 3,243 healthcare practices and businesses.
SOURCE:
Healthcare Success Strategies
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10-21-2009 : WHERE MUSCULOSKELETAL DEALMAKERS & EMERGING COMPANIES CONNECT
JointVentures Conference Announced:
WHERE MUSCULOSKELETAL DEALMAKERS & EMERGING COMPANIES CONNECT
http://www.jointventuresconference.com
A 1-day strategic partnering & investment conference
Dedicated exclusively to start-ups in orthopedics & spine
Prior to North American Spine Society (NASS) Annual Meeting
Registration Special Ends Oct 30 2009
Nov 10 2009 -- Grand Hyatt San Francisco CA USA
Irvine CA USA -- Medical Industry E-Mail News™ -- Oct 21 2009 -- BioMedGPS, LLC, a business intelligence company providing vital decision-making tools for life science executives, has announced that more than 30 emerging orthopedics and spine medical technology companies will take the stage at their JointVentures event on Nov 10 2009, in San Francisco CA, seeking investment and/or strategic partnership opportunities.
Companies presenting and in attendance represent all segments of the high-growth musculoskeletal marketplace, including arthroscopy, orthobiologics, extremities, joint replacement, sports medicine, spine, trauma, image-guided surgery, pain management, and diagnostics.
The JointVentures Conference is an efficient and cost effective way for emerging companies in the musculoskeletal arena to get in front of the dealmakers they need to meet. Nowhere else can you meet the management teams from 30+ privately held orthopedics and spine companies in a single day -- and network with all the major dealmakers in the musculoskeletal industry.
The program will also feature an All-Day Presenter Exhibit and Networking Hall, to maximize networking opportunities.
WHEN & WHERE:
Nov 10 2009
Grand Hyatt Hotel
San Francisco CA USA
http://www.jointventuresconference.com
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10-20-2009 : MICROMED SELECTED AMONG TOP COMPANIES IN NATIONAL VC COMPETITION
MICROMED SELECTED AMONG TOP COMPANIES IN NATIONAL VC COMPETITION
Houston Manufacturer of HeartAssist 5™ Left Ventricular Assist Device Chosen #1 in Region & Among National Finalists
http://www.micromedcv.com
Houston TX USA -- Medical Industry E-Mail News™ -- Oct 20 2009 -- On Oct. 8, MicroMed Cardiovascular, manufacturer of the HeartAssist 5™ left ventricular assist device (LVAD), was selected as one of the Top 50 Emerging Companies in the nation's largest venture capital competition, the Sixth Annual Pitching Across America competition.
"More than 100 VCs and Angel Investors voted us as one of the most promising companies and technologies out there," said Bill Birdsall, MicroMed CEO. "The HeartAssist 5™ is designed to help the heart's failing left ventricle by pumping up to 10 L/min of blood to the body."
Judging criteria consisted of several key points including: current stage of development (customers, revenue), competitive advantage, need in the marketplace and whether the company is "VentureWorthy."
The HeartAssist 5™ pump weighs 92 grams and measures 2.8 x 1.2 inches. Because of its miniature size, it is one of the few LVADs that can be implanted above the diaphragm, adjacent to the heart. The HeartAssist 5™ is the only LVAD with a precise, direct flow measurement system.
In Europe, the HeartAssist 5™, the Modern DeBakey VAD™, has CE Marks for both adult and pediatric use. In the U.S., the HeartAssist 5™, formerly DeBakey VAD® Child, is the only FDA-approved pediatric VAD. A bridge-to-transplant IDE clinical study is currently underway in the U.S. for adults.
SOURCE:
MicroMed Cardiovascular
8965 Interchange Dr
Houston TX USA 77054
http://www.micromedcv.com
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10-06-2009 : Bioassays: Scientific Approaches & Regulatory Strategies Conference; Nov 2-3 2009
BIOASSAYS: SCIENTIFIC APPROACHES & REGULATORY STRATEGIES CONFERENCE SET
http://casss.org/displayconvention.cfm?conventionnbr=6336
-- Design & development of bioassays; Statistical concepts applied to the analysis of bioassays
-- Application of bioassays through the lifecycle of a drug product
-- Use of surrogate binding assays & cell-based, functional assays
-- Comparison of ligand-receptor binding assays with cell-based bioassays
-- Nov 02-03 2009 -- NIH Campus, Bethesda MD USA
Emeryville CA USA -- Medical Industry E-Mail News™ -- Oct 06 2009 -- The opening of registration was formally announced today for the inaugural meeting of Bioassays: Scientific Approaches & Regulatory Strategies, to held Nov 02-03 2009 at Lister Hill Auditorium on the NIH Campus in Bethesda MD.
Background:
Assessment/evaluation of biological activity or potency is a key component of biopharmaceutical development and production. The goal of this meeting will be to provide a forum for presentation and discussion of bioassay methodologies, the application of bioassays during biopharm process development and manufacture, and expectations from regulatory authorities on assessment of biological potency. Active participation of both industry and regulatory will be emphasized.
For registration instructions & complete meeting details:
http://casss.org/displayconvention.cfm?conventionnbr=6336
Why you should attend Bioassays 2009:
Confused by the tangle of information about bioassays? Wonder about which ones to use? How to manage them? The current regulatory expectations? Come to Bioassays 2009, a new CASSS conference that offers current and relevant discussions about many bioassay-related topics including life cycle management, statistical design and analysis, validation and much more.
This meeting will be well-attended by both industry and regulators alike. This is a must-attend conference for professionals involved in bioassay development and regulatory areas who wish to learn more about current thinking and expectations in the field.
To view the preliminary scientific program:
http://www.casss.org/displaycommon.cfm?an=1&subarticlenbr=267&convnbr=6336&showmember=5773433
Who should attend:
This program is designed for scientists in pharmaceutical and biotech companies working in the following functional areas:
Bioassay Development
Bioanalytical Development
Biological assays
Potency assays
Biotherapeutics
Immunotherapeutics
Quality control
R&D
Biopharmaceuticals
Preclinical Development
Manufacturing
Molecular & Cell Biology
Immunology
This program would also benefit contract research organizations (CROs).
Conference topics:
Design & development of bioassays
Statistical concepts applied to the analysis of bioassays
DOE during bioassay development
Application of bioassays through the lifecycle of a drug product
Use of surrogate binding assays & cell-based, functional assays
Comparison of ligand-receptor binding assays with cell-based bioassays
Regulatory principles & expectations for bioassay development, use & validation
Alternatives to the measurement of biological activity
Transfer of complex bioassays to QC environment
Antibody glycosylation & biological activity
Structural analysis of biological activity
New technologies for bioassay development
Workshops:
Setting specifications for bioassays
Design & execution of SAR Studies
DOE during bioassay development
Statistical analysis of bioassays
Program Organizing Committee:
Kimberly Benton, CBER, FDA (Co-Chair)
Chana Fuchs, CDER, FDA (Co-Chair)
Helena Madden, Biogen Idec (Co-Chair)
Robert Strouse, MedImmune (Co-Chair)
Lodging:
A room block is reserved at the Hyatt Regency Bethesda for meeting attendees at the special group rate of $224 for single occupancy and $249 for double occupancy (plus 13% occupancy tax). The room reservation deadline is Oct 8 2009. To make reservations, contact the Hyatt Regency Bethesda: 301-657-1234 phone. Please identify yourself as a participant of “Bioassays” to secure the above rates.
For further hotel information:
http://casss.org/displaycommon.cfm?an=1&subarticlenbr=266&convnbr=6336&showmember=5773433
About CASS:
CASSS is the premier nonprofit scientific society of over 4,000 industry, academic and public sector professionals in the field of separation science. CASSS provides forums for disseminating information and discussions among industry, academic and regulatory professionals, involving the development and applications of separation science. CASSS aspires to become the global leader for communicating the development of technology and applications in separation and related sciences.
SOURCE:
CASSS
http://www.casss.org
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10-05-2009 : Wear Ease Announces New Garments During Breast Cancer Awareness Month
WEAR EASE DESIGNS THE LATEST FASHIONS WITH MASTECTOMY PATIENTS IN MIND
http://www.wearease.com
Boise ID USA -- Medical Industry E-Mail News™ -- Oct 05 2009 -- One in eight U.S. women will be diagnosed with breast cancer during their lifetime, and currently slightly more than half, 56%, undergo mastectomy. Few fashion options exist for those who don't seek reconstructive surgery or postpone it until after their treatment and recovery -- a condition the clothier Wear Ease seeks to remedy.
"Fighting breast cancer is a big enough challenge," says Wear Ease owner Phyllis Keith. "We're trying to help ensure women don't also lose their self-esteem, dignity, and femininity."
Wear Ease designs and markets post-surgery and mastectomy bras, camisoles, loungewear, and lingerie. According to several specialty boutiques, its clothing is in vogue.
"We started ordering their Dawn post-surgery camisole because it's prettier than other brands, and they're flying off the shelves," says Michele Yett, a certified mastectomy fitter at Expressions Appearance Center at St. Jude Medical Center in Fullerton CA. "They're great products -- they come with fiber-filled breast forms and a pair of pouches for drain tubes and bulb syringes, plus they're comfortable, they come in a variety of colors, and they're very desirable in terms of femininity."
Pamela Ludwig RN, who owns Pretty in Pink Boutiques in Franklin and Nashville TN, concurs. "The post-op camisole is so comfortable and stylish a lot of my patients wear them far beyond the post-op period," Ludwig says. "Often they wear a black one as a fashion camisole under a black blouse."
Retailers also say the Wear Ease line helps women feel whole. "They're very up to date with fashion trends," says Sheila Robertsdahl, a certified orthotic/mastectomy fitter and manager of the Just for Women boutique at MeritCare HealthCare Accessories in Fargo ND. "With the way the pockets for the prostheses are designed, nobody can even tell it's a pocketed mastectomy garment."
Ludwig, a registered nurse who worked for 10 years in clinical oncology before opening Pretty in Pink in 2005, agrees, adding, "With off-the-shelf products like these available, women can achieve the look they want without having to undergo reconstructive surgery." However, she says many patients undergoing breast reconstruction use Wear Ease products, too. "A lot of times reconstruction doesn't give a woman the exact symmetrical look she wants," she says, "so you can sometimes fix that with a bra or partial prosthesis."
This month, Wear Ease is introducing a brand-new line: the Alicia adjustable-strap camisole. "This beautiful camisole enables a woman who has undergone breast surgery to wear an alternative top just like she would have worn beforehand," Keith says. "It is designed to accommodate her breast forms and does not require her to wear a special bra underneath." Available in black, coral, kiwi green, and aqua blue, the Alicia camisole comes in S, M, L, XL, 1X and 2X sizes.
The new product is a hit among retailers. "The new Alicia camisole with the lace is going to be a super seller," Robertsdahl says, and Yett says, "We all think it looks darling." "I love the colors available with the Alicia," Ludwig says. "They're very fresh -- there's nothing else on the market with colors like those."
In addition to the Alicia and Dawn mastectomy camisoles, Wear Ease sells post-surgery bras and post-mastectomy nightgowns and T-shirts with reversible necklines. It also sells compression garments, including compression bras, slimmers, and shapers to facilitate healing after surgery or treat swelling in the trunk caused by Lymphedema. Wear Ease garments come standard with shelf bras and pockets for breast forms. All insurance, including Medicare, covers breast forms and pocketed breast-surgery bras and camisoles.
About The Company:
Keith founded Wear Ease in 2001 to provide the Sarah Bra designed for women who have limited mobility. In 2005 the company diversified into the post-mastectomy specialty market and has since grown to include 20 products across five lines.
Wear Ease is a member of Essentially Women, a national purchasing group focused on women's health, and sells through boutiques, hospitals, and durable medical equipment dealers nationwide and online via http://www.wearease.com.
SOURCE:
Wear Ease Inc
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10-05-2009 : Unique Biotech Supply Chain Summit For Marketing & Supply Chain Professionals 60 Top Speakers Announced; South San Francisco CA
SUMMIT OF EXECUTIVES TO ADDRESS ISSUES OF COST REDUCTION, RISK MANAGEMENT, VISIBILITY, TALENT & CAREER DEVELOPMENT, CLINICAL TRIALS MANAGEMENT, & NETWORKED GLOBAL SERVICES IN THE BIOTECH SUPPLY CHAIN
http://www.biosupplyalliance.org/bscaregistration.html
-- Rx For A Lean & Healthy Biotech Supply Chain
-- Providing Solutions for Marketing, R&D, Risk Management, HR, Finance, Sales & Supply Chain Professionals
-- Oct 19-20 2009 -- South San Francisco Conference Center
Calabasas CA USA -- Medical Industry E-Mail News Service™ -- Oct 05 2009 -- The Biosupply Management Alliance (BSMA) announced further details today on its 2nd Annual Conference on profitability and growth, Rx For A Lean & Healthy Biotech Supply Chain.
The two-day conference includes almost 60 top speakers who are key medical industry executives. The Oct 19-20 event, at the South San Francisco Conference Center, will provide an exciting forum for collaboration, learning and best practices.
WHEN & WHERE:
Oct 19-20 2009
South San Francisco CA USA
devendra@biosupplyalliance.org
REGISTRATION & PROGRAM INFO:
http://www.biosupplyalliance.org/events.html
INDUSTRY PANELS
#1 OPERATIONS EXECUTIVES: MANAGING THE ENTERPRISE IN TURBULENT TIMES
Executives of biotech companies will discuss the biggest challenges they have already conquered, are addressing now, and will potentially face. The opportunities, impediments and risks from end-to-end are multi-faceted, such as commercialization of innovations, clinical trials global outsourcing, lean and contract manufacturing, information sharing, visibility and asset management in the supply chain. The panelists will also answer questions - How has the economy changed sourcing and delivery? What will their supply chain look like in five years? This important session provides a forum for an informative Q&A about collaboration along the entire supply chain.
Panelists: Alison Moore PhD, VP of Corporate Mfg, Amgen; Andrew Ramelmeier PhD, VP of Mfg & Process Devel, BioMarin Pharmaceuticals; Dave Malenfant, VP of Global Supply Chain, Alcon Labs; Franklyn Hathaway, Dir, Supply Chain Excellence, Bayer Healthcare; Mark Buck, Global Supply Chain & Procurement Leader, Bio-Rad Labs
Moderator: Devendra Mishra, Adjunct Professor, Graziadio School of Business & Management, Pepperdine University
#2 LAUNCH & COMMERCIAL MANAGEMENT: OVERCOMING THE ACHILLES' HEEL
The commercialization of new products faces significant obstacles in terms of organizational structure, cross-functional collaboration for launch, transfer of knowledge, capacity planning under uncertainty, process control and optimization, and interface with distribution and the market place.
Panelists: Shankar Suryanarayanan, Co-Chairman, Biotech Supply Chain Academy; Fred Gvillo, Entrepreneur Biotechnology; Lee Schruben, Professor of Industrial Engineering & Operations Research, UC Berkeley
Moderator: Wayne McDonnell, Research Dir, Health & Life Sciences, AMR Research
#3 SUPPLY CHAIN RISK MANAGEMENT: SAFEGUARDING THE ENTERPRISE & MAKING IT RESILIENT
The strategic, financial, operational and hazard risks in the industry supply chain, from end to end, will be analyzed and current practices will be discussed with emphasis on information, systems, procedures and collaboration to achieve security, quality assurance.
Panelists: Phil Kaminsky PhD, Assoc Professor, Industrial Engineering & Operations Research, UC Berkeley; Dave Malenfant, Sr VP, Global Supply Chain & Head of Risk Mgmt Committee, Alcon Labs; Chris Sam, Exec Dir, Risk Mgmt, Amgen; Michael Mitchell, Dir, Global Supply Chain Mgmt, SAFC Bioscience; Mohinder Sikka, CEO, Sensitel
Moderator: William Coakley, Sr Dir, Supply Chain Mgmt, SciClone Pharmaceuticals
#4 SUPPLY CHAIN TALENT & CAREER MANAGEMENT: A BIOTECH INDUSTRY PREROGATIVE
Proven solutions will be presented by leaders of the biotech and semi-conductor industry in conjunction with academia for the development of supply chain management professionals for all rungs of the ladder in a biotech enterprise. Development programs range from tactical to strategic management training of professionals.
Panelists: Laura Meade PhD, Assoc Professor, Texas Christian Univ; Phil Kaminsky PhD, Assoc Professor, Industrial Engineering & Operations Research, UC Berkeley; Nabil Rageh PhD, Dir, DBA Program, Golden Gate Univ; Robert Wheeler, Business Process Owner, Plan & Schedule Production, Genentech; Adam Zak, Founder/CEO, Adam Zak Executive Search
Moderator: Jim Kellso, Sr Supply Chain Master, Intel
#5 DISTRIBUTION & FULFILLMENT: ENSURING AGILITY, ADAPTABILITY & ALIGNMENT
Discussion to enhance the value added services between the manufacturer of the drug and the hospitals, doctors and patients. Solutions and best practices will be addressed, such as, collaborative planning, IT linkage, data synchronization, warehousing, transportation, fulfillment services, sustainability of the environment, etc.
Panelists: Ron Bone, Sr VP, Distribution Support, McKesson; Laurel Junk, VP, Procurement & Supply Chain, Kaiser Permanente; Laura Meade PhD, Assoc Professor, Texas Christian Univ; Jim Burleigh, CEO, SmartTurn; Paul Condron, Industry Manager, Dematic
Moderator: Robert Bowman, Sr Editor, SupplyChainBrain.com
#6 VISIBILITY IN THE SUPPLY CHAIN: BUILDING THE HOLY GRAIL
Address the issues of achieving visibility in the supply chain from end-to-end, utilizing ePedigree and the current government legislation, technology solutions, legal framework and best practices. A framework for Track-and-Trace being adopted by the food industry consisting of a technology-based infrastructure and software will also be discussed.
Panelists: Angela Watson, Corp VP, Strategic Accounts, UPS; Joe Puleo, VP, Customer Devel, Exel; Mohinder Sikka, CEO, Sensitel; Colin Finn, VP of Sales, Pelyco Systems; Ron Bone, Sr VP, Distribution Support, McKesson
Moderator: Tom Magill, Exec Consultant, Judgment Index
#7 LEVERAGING PARTNER NETWORKS TO MEET SUPPLY CHAIN CHALLENGES OF EMERGING BIOTECH
World-class services are available for the biotech industry - incubators, contract research, CRO, contract manufacturing and 3/4PLs, in the US as well as globally to overcome constraints of capacity, competencies and investments. Presentations will be made by companies across the globe which provide world-class services for the segments of the supply chain.
Panelists: Ron Susek, Principal, PRTM; Tom Privette, VP, Strategic Partnering, Covance; Alison Moore, VP; Gustavo Mahler, President, C/M/C ICOS Biologics Alison Moore PhD, VP, Corporate Mfg, Amgen
Moderator: PRTM Executive
#8 DEVELOPING FLEXIBLE MANUFACTURING: OVERCOMING CONSTRAINTS & ENHANCING EFFICIENCY
The panel will identify proven approaches for producing multiple products in a flexible manufacturing environment. The challenges to be addressed - segregation, quick changeover, inventory management, disparate cells or product types, operator costs and ease of technology transfer. The pros and cons of building in a single site vs diversifying to multiple sites will be analyzed. Key considerations include business continuity risks, availability of diverse expertise and capabilities, such as bulk production versus fill finish activities and business incentives.
Panelists: Andrew Ramelmeier PhD, VP of Mfg & Process Devel, BioMarin Pharmaceuticals; Robert Bottome, Head of Operational Excellence, Genentech; Nabil Rageh, Dir, DBA Program, Golden Gate Univ; Dave Zaleski, Industry Mgr, Dematic
Moderator: Tim Salaver, Exec VP, Operations & Technology, Bio Supply Management Alliance
#9 4Ts OF COLD CHAIN: TECHNOLOGY, TRACKING, TEMPERATURE-CONTROLLED TRANSPORTATION
An innovator in Cold Chain, an RFID provider with hosted offerings, industry standards organization and a leading biopharm company will address how to move the industry to more consistent, better understood and ultimately lower cost temperature assurance transport solutions. Solutions will be presented and discussed for expanded deployment of the technology from the clinical and bulk arenas to the commercial environment. The transfer of knowledge on scalable platforms is a large piece of the puzzle when looking to reduce total cost of ownership.
Panelists: Rodney Derifield, President/Founder, EnviroCooler; Ed Church, Exec Dir, Intl Safe Transit Association; Frank Newman, Managing Dir, Enterprise & Regional Account Mgmt, FedEx; Garry Hutchinson, Dir, Global Transportation, Amgen; Jim Cox, CEO, Temp Trip
Moderator: Rodney Derifield, President/Founder, EnviroCooler
#10 CLINICAL TRIALS SUPPLY CHAIN THROUGH DEMAND & OPERATIONS PLANNING
The ability to map clinical trial demand streams, understand demand variability, and developing segmented clinical trial supply responses would yield significant benefits for life sciences companies. In this session clinical supply chain demand forecasting will be examined in the context of broader clinical trial resource alignment and a new, highly accurate demand forecasting platform. This session will also introduce a five-step process in the Demand Rationalization & Operations Planning (DR&OP) adopted from the traditional S&OP process and how you can use DR&OP within your clinical trials to balance demand and supply to achieve peak performance.
Panelists: Andrew Ramelmeier, VP, Mfg & Process Devel, BioMarin Pharmaceuticals; Arun Cavale, CEO, Nexinfo; Krish Ghosh, VP, Strategic Sourcing, Covance; Tom Privette, VP, Strategic Partnering, Covance
Moderator: Wayne McDonnell, Research Dir, Health & Life Sciences, AMR Research
ANOTHER 8 REASONS NOT TO MISS THE SUMMIT
#1 "The Biotech Industry: $ & Sense"
The biotech industry has thrived as a new drug incubator for big pharma companies, which have poured money into acquisitions and partnerships to build up their biotech product line. A worldwide authority will take stock of the economic performance and outlook of companies, products, technologies, investments, consolidations, competitive environment and governmental regulations.
Casey McGlynn, Partner, Wilson Sonsini Goodrich & Rosati
#2 "Regulatory Influences in Biogenerics - The Next Generation"
Presentation of scientific and science policy issues in connection with legislative, regulatory, public affairs, and communications initiatives involving the government, industry, the research community, and effective collaboration practices with regulatory agencies in discovery, development, and manufacture of biotech-based medicines.
Gillian R. Woollett, Chief Scientist, Engel & Novitt
#3 "Why Collaborate in the Biotech Supply Chain?
Global competition to reach emerging markets, increased pressure on pricing and reimbursement, under-utilized capacity of large manufacturing facilities and expensive stocks of inventory are all calling the biotech supply chain executive to action to unlock sustainable value. AMR Research will preview their first annual Healthcare Top 25 ranking.
Wayne McDonnell, Research Dir, Health & Life Sciences, AMR Research
#4 "Developing Careers in Supply Chain Management: A Blueprint"
A Case Study of the development of supply chain management talent at Intel and the practical search for professionals at a recruiting firm.
James R. Kellso, Sr Supply Chain Master, Intel
Adam Zak, Principal/Founder, Adam Zak Search Recruiter
#5 "The Building Blocks of A World-Class Distributor"
Distribution in the biopharma industry has expanded its services with extraordinary results. The information-driven service provider will highlight how customer-centricity can be achieved while reducing costs and lead-time and improving asset utilization.
John Figueroa, President, McKesson US Pharmaceutical
#6 "Rx 360: Global QA for Suppliers"
A Deming-based industry initiative to develop operating standards, share data and create an independent supplier audit function to improve the efficiency, oversight and accountability of the bio-pharmaceutical supply chain, leading to standardization of best practices and establishment of world-class suppliers.
Martin VanTrieste, VP, Quality, Amgen
#7 "Profiting From Lean Six Sigma in Biotech: Experiences of The Best"
A Case Study of the successful evolution of lean six sigma principles
from the automotive to discrete manufacturing to biotech will be analyzed to demonstrate contribution to the bottom line.
Edgar Sur, Head of Operational Excellence, Bayer Healthcare
#8 "4Ts of Cold Chain: Technology, Tracking, Temperature-Controlled Transportation"
Innovations in cold chain to achieve lower-cost temperature transportation from clinical and bulk to commercial areas.
Rodney Derifield, CEO/Founder, Envirocooler
NETWORK, MARKET, LEARN & SHARE WITH INDUSTRY EXECUTIVES & ACADEMIA
Over 200 executives expected from about 80 companies and universities.
TO REGISTER:
http://www.biosupplyalliance.org/bscaregistration.html
Further Details:
To Register: dotti@biosupplyalliance.org
Program: devendra@biosupplyalliance.org
Sponsorship: arleen@biosupplyalliance.org
Telephone No. 818-224-1552
About the Biosupply Management Alliance:
The Biosupply Management Alliance was created for the worldwide community of operations and supply chain management leaders and professionals in the biotech, biopharm and biomed device industries. Based in the San Francisco Bay Area, home to more than 600 bio firms, BMA provides a forum for collaboration, learning and best practices.
SOURCE:
Biosupply Management Alliance
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10-02-2009 : Drug Information Association (DIA) 7th Canadian Annual Meeting -- Overcoming Global Healthcare Challenges
DIA 7th CANADIAN ANNUAL MEETING TO EXPLORE STRATEGIES FOR OVERCOMING GLOBAL HEALTHCARE CHALLENGES
Nov 02-04 2009 -- Ottawa Ont Canada
Horsham PA USA -- Medical Industry E-Mail News™ -- Oct 02 2009 -- The Drug Information Association (DIA) will host the 7th Canadian Annual Meeting on Nov 02-04 2009 in Ottawa Ont Canada.
The 7th Canadian Annual Meeting will address changes within the Canadian and global regulatory environments, efficiency and safety in the development of therapeutics, the latest domestic and international processes in conducting clinical trials, monitoring of therapeutics and transparency.
Parallel tracks in clinical development, safety/pharmacovigilance and regulatory affairs will include sessions on:
-- Role of REBS in the Protection of Human Subjects: Special Populations
-- Evolving Safety Science
-- Development in Biosimilars in Canada, US, Europe, ICH & WHO
-- Pharmacogenomics
-- Pharmacovigilance Operations
-- What Is Your Role in Facilitating Patient Access?
-- Site Audits & Inspections
-- Patient Risk Management
-- Electronic Interface with Health Canada 2009-2010
-- Ethical Issues in Clinical Trials
-- New Directions in Safety Outcome Research: DSEN, Sentinel, ENCEPP
-- Orphan Drugs
Pre-meeting tutorials on Nov 2 will focus on:
-- Design & Analysis of Cluster Randomization Trials in Clinical Research
-- Risk Communication
-- Health Canada's Initiatives to strengthen the Natural Health -- Products Program: Focus on "eTools"
Paul Crotty, General Manager, IMS Canada, and Bob Nakagawa, Assistant Deputy Minister, Pharmaceutical Services, British Columbia Ministry of Health Services, will deliver the keynote address.
"The biopharmaceutical and related sectors face many challenges, including the need for increased transparency, the unpredictable global economy, and the evolution of drug development," explains Program Co-chair Agnes V. Klein MD DrPH, Director, Center for Evaluation of Radiopharmaceuticals & Biotherapeutics, Biologics & Genetics, Therapies Directorate, HPFB, Health Canada. "The 7th Canadian Annual Meeting will address all of these challenges."
Click here to register for the 7th Canadian Annual Meeting:
About the Drug Information Association (DIA)
DIA serves more than 30,000 professionals involved in the biopharmaceutical industry and regulatory affairs worldwide. Through its domestic and international meetings, training courses, workshops and webinars, DIA provides a neutral global forum for the exchange of information critical to the advancement of the drug discovery and lifecycle management processes. Headquartered in Horsham PA USA, and with offices in Basel Switzerland, Tokyo Japan, Mumbai India, and Beijing China, the Association is led by its volunteer-based Board of Directors and executive management team.
SOURCE:
Drug Information Association
http://www.diahome.org
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10-01-2009 : Ash Attia Joins MicroMed Cardiovascular as VP of Asia-Pacific
ASH ATTIA JOINS MICROMED CARDIOVASCULAR AS VP OF ASIA-PACIFIC
-- Industry Veteran to Bring HeartAssist 5™ Left Ventricular Assist Device to Asia Subcontinent, Australia & New Zealand
http://www.micromedcv.com
Houston TX USA -- Medical Industry E-Mail News™ -- Oct 01 2009 -- MicroMed Cardiovascular, manufacturer of the HeartAssist 5™ left ventricular assist device (LVAD), announced today that Ash Attia has joined the company as Vice President of Asia-Pacific. Attia will be responsible for the launch, management and expansion of the HeartAssist 5™ in the region, which includes China, Japan, India, Southeast Asia, Australia and New Zealand.
“Ash has more than 20 years of experience in medical devices and expanding cutting edge technology into the Asia-Pacific region,” said Bill Birdsall, MicroMed CEO. “His knowledge and leadership are critical to bringing the HeartAssist 5™ to an underserved patient population in need of our life-saving technology.”
Attia has held several senior executive roles within the medical devices industry. Most recently, Attia held the position of Vice President of Asia-Pacific for Ventracor Limited, an Australian manufacturer of ventricular assist devices.
Prior to Ventracor, Attia founded Biotronik Australia and subsequently Biotronik Asia Pacific. As Vice President and Managing Director, he expanded business throughout the region in cardiac rhythm management devices, vascular interventions and electrophysiology.
Prior to this, Attia was General Manager of Sulzer International’s Cardiovascular division, where he managed a group of companies in the areas of cardiac rhythm management, vascular devices, cardiac surgery and electrophysiology.
The HeartAssist 5™ pump weighs 92 grams and measures 2.8 x 1.2 inches. Because of its miniature size, it is one of the few LVADs that can be implanted above the diaphragm, adjacent to the heart. The HeartAssist 5™ is the only LVAD with a precise, direct flow measurement system.
In Europe, the HeartAssist 5™, the Modern DeBakey VAD™, has CE Marks for both adult and pediatric use. In the U.S., the HeartAssist 5™, formerly DeBakey VAD® Child, is the only FDA-approved pediatric VAD. A bridge-to-transplant IDE clinical study is currently underway in the U.S. for adults.
SOURCE:
MicroMed Cardiovascular
8965 Interchange Dr
Houston TX USA 77054
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10-01-2009 : Bioworld Today Releases New Executive Compensation Report 2010
BIOWORLD TODAY RELEASES NEW REPORT: THE EXECUTIVE COMPENSATION REPORT 2010
http://www.bioworld.com/ecr2010
-- 115 pages
-- Compensation packages at 224 publicly traded biotech companies
-- Exact dollar amounts of individual salaries, bonuses & stock options
-- Includes charts, tables, & graphs to illustrate executive compensation
Atlanta GA USA -- Medical Industry E-Mail News™ -- Oct 01 2009 -- The newspaper of record for the biotech industry, BioWorld Today, has published the new BioWorld Executive Compensation Report 2010, now available to industry professionals. The report provides many perspectives on compensation issues by means of key statistics and graphic analyses.
With BioWorld Executive Compensation Report 2010:
Determine where you rank among your peers in terms of compensation packages
Look-up exact dollar amounts of individual salaries, bonuses & stock options
Analyze data on salary increases from the prior year
Reference dozens of charts, tables, & graphs to illustrate executive compensation in the biotech industry
"Companies of every size across the full range of research sectors - from new public companies to industry giants - are covered, using a variety of rankings and comparative listings along with detailed information concerning each company," says Managing Editor Glen Harris. "This critical examination of executive compensation is a must-have for anyone directly involved in executive compensation within the biotechnology industry."
WHO NEEDS THIS REPORT:
Investors & analysts evaluating companies
HR committees, recruiters & boards of directors structuring compensation plans
Executives in the industry comparing how they rank among their peers
INFORMATION AVAILABLE ONLINE:
To view the table of contents, samples pages, and to obtain ordering information, please visit:
http://www.bioworld.com/ecr2010
HOW TO ORDER THIS REPORT:
The full version of the report is available in print. Orders can be placed online at:
http://www.bioworld.com/ecr2010
For priority delivery, please call 404-262-5476 or 800-688-2421.
ABOUT BIOWORLD:
BioWorld, published by AHC Media LLC, is an internationally recognized information provider for executives, analysts and investors following the day-to-day developments in the biotech, pharmaceutical and medtech markets. Focusing on scientific business news and information, BioWorld's websites provide access to daily developments in these sectors, as well as 18 years' worth of archived data, trends and company information.
Key products include BioWorld Today -- the newspaper of record for the biotech industry; BioWorld Insight -- a weekly monitor of biotech's financial markets; BioWorld International -- focusing on life science developments in Europe; and Medical Device Daily -- delivering daily business intelligence for the medtech industry.
SOURCE:
BioWorld Today
3525 Piedmont Rd NE Bldg 6 Ste 400
Atlanta GA 30305-1515 USA
http://www.bioworld.com/ecr2010
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10-01-2009 : EuroPLX To Feature Dynamic Pharma Partnering Focus Concept; Early Registration Deadline is Oct 12
10 YEARS OF THE CONTINUOUS BUSINESS DEVELOPMENT CONCEPT ARE FEATURED IN BARCELONA PHARMA PARTNERING CONFERENCE
http://www.europlx.com
-- euroPLX 41 Barcelona Early Registration Deadline is Oct 12 2009
-- Pharma partnering conference to focus on reducing the amount of time needed to bring new products to market
-- Nov 02-03 2009 -- euroPLX 41 Barcelona Spain
Dielheim/Heidelberg Germany -- Medical Industry E-Mail News™ -- Oct 01 2009 -- Ten years ago, euroPLX introduced the concept of "Continuous Business Development" with pharma partnering events, which are held several times a year. Meeting organizers stress the hybrid format will provide a much more productive and necessary continuity for business development for the popular event.
euroPLX 41 Barcelona will be held on Nov 02-03 2009 in the Hilton Diagonal Mar, Barcelona Spain.
BACKGROUND:
This particular business development style was created because of the realization that partnering for business development is not an activity that is initiated and completed within a few weeks. Consequently, this led to the conclusion that once-a-year partnering events are not sufficiently suited to meet the requirements of seasoned business development professionals.
With this in mind, the organizers of euroPLX introduced the concept of "Continuous Business Development" in Nov 1999, after having been held only once in each of the four previous years.
The concept provides for several events evenly distributed over the year. Now, after 10 years, the "Continuous Business Development" concept is widely accepted as a most effective and economic way to reduce time for business development activities and, therefore, reduce the time to bring new products to the market, which is essential in the current economic situation.
REGISTRATION DEADLINE:
The registration deadline for the upcoming euroPLX 41 Barcelona will be on Oct 12 2009. The event spaces are close to fully booked. Pharma and biopharma companies from 30 countries are currently registered, with 28% newcomer companies which never attended a euroPLX Meeting before.
This is a very popular pharma industry partnering event, with industry delegates from all over the world. Historically, this partnering event delivers an average of more than 23 pre-scheduled appointments per participating company. The partnering scope ranges from innovative to generic, from early stage candidates, to approved, prescription or OTC drugs. In particular, registrants determine the dynamically evolving focus, which is displayed as "Dynamic Partnering Focus."
REGISTRATION DETAILS:
1,300 Euro per delegate (regular). There are also special conditions for early enrollments and for multiple enrollments.
Registration is limited to about 100 companies (one or several delegates)
Registration period ends Oct 12 2009 (there are no registrations after this date - except for additional delegates of already registered companies)
APPOINTMENTS:
Main session time frame for appointments:
Mon Nov 02 2009 (09:30h - 18:00) and Tues Nov 03 2009 (08:30 - 16:30h).
The four session blocks will provide maximum flexibility for your individual travel itinerary, while ensuring the highest efficiency possible.
VENUE:
Hilton Diagonal Mar, Barcelona Spain
REGISTERED COMPANIES:
The country names designate the places where the attending delegates are based, not necessarily the respective company's headquarters:
Abdi Ibrahim Pharmaceuticals (Turkey)
Actavis A/S (Denmark)
AET (Alfred E. Tiefenbacher) (Germany)
Alapis SA (Greece)
Aldo-Union Laboratorio SA (Spain)
Alkalon A/S (Denmark)
Angelini Farmaceutica SA (Spain)
Annahdah Medical Co (Saudi Arabia)
AXIS Clinicals Ltd (India)
BC World Pharm (Korea Republic of)
Bifodan A/S (Denmark)
Biogened SA (Poland)
Bioiberica SA (Spain)
Biointer / Feron Ltd (Russia)
Biolab Sanus Farmaceutica Ltda (Brazil)
BioPhausia AB (Sweden)
Bioselenia SL (Spain)
BioSphings AG (Germany)
Bioxtract (Belgium)
Chanelle Medical Ltd (Ireland)
Chemi SpA (Italy)
Combino Pharm (Spain)
Daewoong Pharmaceutical Co Ltd (Korea Republic of)
Duchesnay Inc (Canada)
Efarmes SA Unipersonal (Spain)
Eriochem SA (Argentina)
Ethypharm SA (France)
European Packaging Centre bv (Netherlands)
Fannin Limited (Ireland)
Farmalider SA (Spain)
FarmaSyn SA (Greece)
Ferrer Intl SA (Spain)
Flamingo Pharmaceuticals Ltd (India)
Geiser Pharma SL (Spain)
Genepharm Group (Greece)
GES - Genericos Espanoles SA (Spain)
GP Pharm SA (Spain)
Gumlink A/S (Denmark)
Helvetia Pharma AS (Czech Republic)
Hennig Arzneimittel GmbH & Co KG (Germany)
Hikma Farmaceutica (Portugal)
Hovione (USA)
ICE Pharma Group (UK)
Jubilant Pharmaceuticals NV (Belgium)
Keymen Ilaç Sanayi ve Ticaret Ltd Sti (Turkey)
Krka DD (Slovenia)
Laboratoires Pierre Fabre SA (France)
Laboratorios Kin SA (Spain)
Laboratorios Llorens SA (Spain)
Laboratorios Salvat SA (Spain)
Lacer Personal Health (Spain)
Medochemie Ltd (Cyprus)
Merck KGaA (Germany)
Merck Sharp & Dohme (Belgium/Europe)
Merz Pharma GmbH & Co KGaA (Russia)
Micro Labs Ltd (India)
Moberg Derma AB (Sweden)
Mundipharma Pte Ltd (Singapore)
National Research Company Ltd (Russia)
Neogen NV (Belgium)
OM Pharma (Switzerland)
Orivas (Lithuania)
Oystershell nv (Belgium)
PanGenerika BV (Netherlands)
Pharmatec Pakistan Pvt Ltd (Pakistan)
Pharmathen UK Ltd (UK)
Pharmis Biofarmaceutica Lda (UK)
Pinewood Healthcare Ltd (Ireland)
Piramal Healthcare (UK)
Prolepha Research BV (Netherlands)
ratiopharm GmbH (Germany)
Salveo Doo (Croatia)
Sanofi-Aventis Group (France)
Sanofi-Aventis Zrt (Hungary)
Sinclair Pharma SrL (Italy)
Sinclair Pharmaceuticals Ltd (UK)
SkyePharma (Switzerland/France)
SolPharma Ltd (Israel)
Suan Farma SA (Spain)
Sun Pharmaceuticals Europe (UK/Netherlands)
Synthon BV (Netherlands)
Technology Catalysts Intl (USA)
Teva Europe (Romania)
TTY BioPharm Co Ltd (Germany)
Winthrop Arzneimittel GmbH (Germany)
ABOUT US & EUROPLX:
euroPLX® (short for European Pharma License Exchange) is a brainchild and Europe registered trademark of RauCon. As a specialist consultancy for providing and organizing collaborative opportunities, RauCon caters to international pharma and biopharma business development and licensing executives, with organizational tools for the optimization of the business development process, advice, and career support.
Having organized partnering events in Europe, North America, and Australia since 1987, RauCon has pioneered the Pharma License Exchange concept in 1995, a novel business development platform for the pharmaceutical industry. Since then each single euroPLX Meeting was meticulously planned and prepared by Dr. Norbert Rau and Mrs. Anke Rau who have an up-to-date perspective on the industry since more than two decades.
SOURCE:
RauCon Business Development
Kurfurstenstrasse 1A
Dielheim 69234 Germany
http://www.europlx.com
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09-30-2009 : Noblitt & Rueland FDA Regulatory Training Hotel Room Block ends this Friday Oct 2; San Francisco Bay Area
5 REGULATORY TRAINING COURSES TO DISCUSS FDA ENFORCEMENT & INTL COMPLIANCE ISSUES IN SAN FRANCISCO BAY AREA
http://www.fdatraining.com/trains.shtml
-- FDA cites training violations in 30% of Warning Letters -- see info bullet below for more details
-- Topics that have become top priority for FDA investigators & reviewers will be covered along w/key intl compliance problems
-- Goal of training is to help companies avoid regulatory enforcement action & be more efficient in the process
-- Oct 26-30 2009 -- Embassy Suites on the San Francisco Bay, Burlingame CA USA
-- Discounted Hotel Room Block ends this Friday Oct 2
Irvine CA USA -- Medical Industry E-Mail News Service™ -- Sept 30 2009 -- Noblitt & Rueland today announced further details of its comprehensive regulatory seminar schedule for Oct 2009. All events will be held at the Embassy Suites Hotel on the San Francisco Bay, Burlingame CA USA.
Topics that have become top priority for FDA reviewers and compliance inspectors will be covered, to help protect you and your company from severe regulatory enforcement action.
OCT COURSES: EMBASSY SUITES ON THE SAN FRANCISCO BAY, BURLINGAME CA (attend any 1 or more training programs)
Oct 26; Mon -- FDA Quality System Regulation (QSR/GMP) & FDA Inspections
Oct 27; Tues -- Auditing Quality Systems for FDA & ISO Compliance
Oct 28; Wed -- Design Control, the FDA & ISO
Oct 29; Thu -- Risk Management, ISO 14971 & FDA Requirements
Oct 30; Fri -- Software Verification & Validation Strategies
VENUE:
Embassy Suites on the San Francisco Bay, Burlingame CA USA. Convenient to San Francisco Airports, downtown San Francisco & Silicon Valley. Special course discounts, including multiple attendee discounts, are available. Discounted hotel room block ends this Fri Oct. 2.
Course Descriptions:
To Download A Seminar Brochure:
To Register:
For Registration & Hotel Info:
CRITICAL NEWS HIGHLIGHTS: FDA & ISO MEDICAL DEVICE HOT TOPICS:
FDA CITES TRAINING VIOLATIONS IN 30% OF WARNING LETTERS. The "Silver Sheet" published by Elsevier Business Intelligence recently published a special report, revealing a significant increase in FDA citations regarding employee training violations. The number of Warning letters issued by FDA that cited training deficiencies jumped from 22% to 30% in 2008. Overall training programs are discussed, with QSR & Inspections, risk management & ISO 14971, design controls, 21 CFR Part 11, up-to-date training records, and the importance of auditing being specifically mentioned in the report. (See “The Silver Sheet”, Vol 13 No 8, Aug 2009) These topics and others will be discussed during the training program to be held Oct 26-30 in the San Francisco Bay Area, Burlingame CA.
NEW ADMINISTRATION in the White House and new FDA Commissioner means new direction for the FDA. Recent high profile cases and outside agency government reports indicate that additional QSR enforcement, oversight, more rigorous 510(k) reviews, and additional regulation are not just on the horizon, but are now happening. Below we discuss some of these activities and during our training we will be discussing the potential impact of all of these critical actions to medical device manufacturers.
FDA CHANGES POLICY ON WARNING LETTER REVIEWS. FDA is changing their program on the issuance of warning letters in an effort to facilitate the issuance of warning letters in a timelier manner. Beginning Sept 15, the adequacy of written responses by an inspected company to FDA 483 observations that are received within 15 days of the FDA 483 being issued will be considered in determining whether a warning letter should be issued. The adequacy of the 15 day response will also be recognized in the warning letter if it is issued. Reponses to FDA 483 observations received after 15 days will be reviewed along with other documents and information received in response to a warning letter when issued.
FDA QUALITY SYSTEM INSPECTION RESULTING IN 510(K) REVIEWS & POSSIBLE WITHDRAWS. A recent FDA quality system inspection of a company in southern California and the resulting Warning Letter comments suggest to the receiving company that it should review several previously cleared 510(k) applications and consider withdrawing the cleared applications, if the data is thought to be unreliable or unverifiable. Companies submitting 510(k)s need to be aware that data supporting the 510(k) may be investigated during your quality system inspection.
DESIGN CONTROL & SOFTWARE CONTINUE TO BE COMPLIANCE ISSUES BEING CITED IN FDA WARNING LETTERS. Companies have received warning letters for design control related issues including issues such as inadequate software verification & validation for device, production, and quality system software; and risk management activities. Proper risk management activities and documentation have helped companies comply and demonstrate the adequacy of their design control activities.
510(k) PROGRAM MODIFICATIONS POSSIBLE. FDA's role or lack of oversight on manufacturer's decisions when deciding not to submit information to FDA regarding device modifications is being questioned by Senator Grassley of Iowa in a letter sent to the Acting FDA Commissioner and the overall 510(k) process is being reviewed. Manufacturers may be greatly impacted if the agency changes their current policy & guidance on 510(k)s and when to submit a new 510(k) for changes to a device.
LAST DAY TO DISTRIBUTE PRODUCT UNDER THE OLD VERSION OF THE MDD IS MARCH 21 2010. After that, all distributed product must comply with the 2007 revision of the MDD. The same date applies to the revision of the AIMDD. You have just approx. 7 months left to update all technical files and design dossiers. Although the installed base is not affected, there is no grandfathering for products distributed after March 21 2010 (regardless of how long the version has been distributed previously in Europe). Please call or email if you have questions or need assistance in complying and meeting the deadline.
ENFORCEMENT ACTIONS ARE VERY COSTLY. Judgments and enforcement actions by the FDA should motivate companies and their management to ensure that their companies are compliant with the Quality System (QS/GMP) regulations. Enforcement actions resulting from GMP/QS regulation violations have been very serious; they have included consent decrees, $100+ mln & $500+ mln fines, corporate warning letters, injunctions to stop manufacturing due to QSR and Design Control issues, and intl firms receiving import detention, etc. A recent US District court complaint against a US medical device manufacturer specifically cites inadequate quality system training of both employees and management in support of a seizure order.
SEVERITY OF ENFORCEMENT PENALTIES HAS INCREASED. Repeat offenders and management should beware of this worsening potential.
REQUIREMENT FOR INTERNAL AUDITING WHEN PERFORMED EFFECTIVELY HAS SAVED MANY COMPANIES BOTH ENFORCEMENT HEADACHES & PENALTIES. Companies have avoided negative competitive and investor relations by finding and correcting deficiencies prior to FDA inspections. These corrections have prevented FDA enforcement actions and Warning Letters from being issued, published on the Internet, and being available to competitors for distribution to customers. In addition, many companies have found that investors become nervous when FDA enforcement actions occur. Obviously, many times the firms experience a negative impact to their stock price or funding.
Program Brochure:
Course-Specific Info Includes a Brief Outline for Each Course:
For Additional Hotel & Registration Info:
Printed brochures and registration are available by phone at 714-258-4646 or 888-892-4664 (in the US & Canada).
SOURCE:
Noblitt & Rueland
http://www.fdatraining.com/trains.shtml
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09-29-2009 : Medical Product Outsourcing Symposium East (MPO) Agenda Announced; Oct 27-28 2009
Medical Product Outsourcing Symposium East (MPO) Agenda Announced
http://www.mposymposium.com
-- Oct 27-28 2009 -- Conference Center at Waltham Woods, Waltham MA
-- Speakers: Dave Busch, John Purlee, Andres Rochwerger, Maggie Pax
-- Register by 10/9, save $200 off registration; additional $200 discount to MassMedic members
Ramsey NJ USA -- Medical Industry E-Mail News™ -- Sept 29 2009 -- Medical Product Outsourcing Magazine is hosting its Medical Product Outsourcing Symposium East on Oct 27-28 2009 at the Conference Center, Waltham Woods, Waltham MA.
The practice of outsourcing continues to present challenges to medical devices manufacturers. This event is a high-level educational and networking program, designed to offer relevant information for solving business-critical issues in an environment that fosters interaction and industry development.
To Register: http://www.mposymposium.com
Who Should Attend:
Leading Companies in:
Medical Device Manufacturing
Contract Manufacturing
OEMs
Finished Goods Manufacturers
Consulting & Financial Services
Sessions Include:
Keynote Address: Exploring a Start-up Model: Maximizing Benefits & Minimizing Risks
Maggie Pax, VP Business Development, MicroCHIPS Inc
Managing the Total Product Life Cycle: Lowering Costs While Increasing Quality
Dan Matlis, Founder/President, Axendia
Supplier Relationship Management: Building Better Partnerships Through Transparency
Joe Kelly, Dir, Tefen USA
Andrew Schramm, Partner, Tefen USA
Networking Luncheon Sponsored by: Ximedica
Leveraging Software Solutions for Best Product Outcomes: A Change for the Better
Morgan Palmer, CTO, EtQ Inc
Valuable Tools To Minimize Early Stage Development Risks: From Feasibility Analysis to Design Considerations
Ken Fine, President/Co-Founder, ProvenProcess Medical Devices
OEM & Supplier Panel: Top Ten Metrics Used for Sourcing Decisions
Moderator: Christopher Oleksy, President, Atek Medical
Panelists:
Tom Black, VP OEM Sales & Marketing, B. Braun OEM Div
Tom Burns, VP Sales & Marketing, Tegra Medical
Rick Desmarais, Worldwide Supply Chain Director, DePuy Mitek
John Purlee, Dir of Global Sourcing, Abbott Diabetes Care
Andres Rochwerger, Global Sourcing Mgr, Boston Scientific Corp
Rachel Starr, Dir of Program Management, Covidien
Cocktail Reception Sponsored by: Covidien
Medical Device Manufacturing Markets Update in an Economic Downturn
Benjamin Dunn, Managing Director, Covington Associates
Improving Enterprise Profitability Through Outsourcing - Making It a Reality
Philip Borden, General Partner, Riverside Partners
Dave Busch, Sr Dir Outsourcing Services, SVTC Technologies
Finding Ways to Accelerate Time to Market & Minimize Risk
Aidan Petrie, Co-Founder/CIO, Ximedica
Networking Luncheon Sponsored by: Tegra Medical
Interactive Workshop: Reimbursement Strategies for Devices to Succeed in the Ever-Changing Medicare & Private Pay Markets
Workshop Leader: Stephanie Mensh MPA, VP of Health Policy & Advocacy, Neocure Group LLC
Sponsored by: MDMA
For latest event updates find us on LinkedIn or follow us on Twitter
SOURCE:
Rodman Publishing
http://www.rodpub.com
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09-28-2009 : Register for Medical Device Compliance Congress by Friday 10/3 for Early Bird Rate
REGISTER FOR 4TH MEDICAL DEVICE REGULATORY, REIMBURSEMENT & COMPLIANCE CONGRESS BY FRIDAY 10/3 FOR EARLY BIRD RATE
http://www.devicecongress.com/registration.html
-- Hybrid Conference & Internet Event
-- Benchmarking Your Firm's Domestic & Intl Practices in Quality Systems, Reimbursement, Fraud, Abuse & Promotion
-- Nov 09-11 2009
-- Onsite: JW Marriott Hotel, Washington DC -- Online: In Your Own Office or Home live via the Internet with 24/7 Access for 6 Months
-- Register By Friday Oct 9 For Early Bird Discount
Washington DC USA -- Medical Industry E-Mail News Service™ -- Sept 28 2009 -- The Medical Device Congress will take place on Nov 09-11 2009 at the JW Marriott Hotel in Washington DC, organizers announced today.
FEATURING SPECIAL SESSIONS ON:
Implications of National Health Reform for the Medical Device Industry
Federal Initiatives in Comparative Effectiveness Research (CER)
Federal Panel: Key Congressional Transparency Initiatives
State Panel: State Disclosure Initiatives
Operational Implications of State & Possible Federal Disclosure Requirements
New Trends in Social Media & New Media
Implementation of the AdvaMed Code
After the Implementation: Maintaining an Effective Compliance Program
Primer for Certifying Compliance with the AdvaMed Code
Federal State Enforcement & Prosecution Initiatives
Fair Market Value (FMV) Analysis Across Various Healthcare Professional (HCP) Arrangements
FDA/CDRH Regulatory & Compliance Update
Medicare Coverage & Payment for Medical Device Update
Coverage & Reimbursement for Medical Devices Abroad Update
Compliance Process Excellence: Implementation of Better Compliance Practices
Global Compliance Best Practices Roundtable
Medical Device Compliance Professional & Legal Counsel Best Practice Roundtable
FEATURING LEADING GOVT REGULATORS & PROSECUTORS:
Carolyn M. Clancy MD, Dir Agency for Healthcare Research & Quality, Rockville MD
Emilia DiSanto, Chief Investigator for Senator Grassley (R-IA), Washington DC
David Hart Esq, Asst Attorney General, Oregon Dept of Justice, Salem OR
Sanjay J. Koyani MPH, Dir FDA Web Communications, FDA Office of Public Affairs, Rockville MD
Jack Mitchell, Chief of Oversight & Investigations, Special Committee on Aging, US Senate; Former Dir FDA Commissioner's Office of Special Investigations (OSI), Washington DC
Kirk Ogrosky Esq, Deputy Chief, Fraud Section, Criminal Div, US Dept of Justice, Washington DC
Gerald Sullivan Esq, Asst US Attorney, US Attorney's Office, E District of PA, Philadelphia PA
Casper E. Uldriks JD MD, Assoc Dir for Regulatory Guidance & Govt Affairs, FDA Center for Devices & Radiological Health (CDRH), Silver Spring MD
DEVICE COMPANY COMPLIANCE PROFESSIONALS & LEGAL COUNSEL:
Mark N. Bonaguro Esq, Chief Compliance Counsel, Covidien, Mansfield MA
Jeffrey E. Cohen, Dir of Compliance, Globus Medical Inc, Audubon PA
Daniel J. Garen Esq, Chief Compliance Officer & Sr Counsel, Siemens Healthcare Sector, USA, Malvern PA
Jacqueline K. Huber, Corp VP & Chief Compliance Officer, Biomet Inc, Warsaw IN
Larry Montes MBA, VP Health Care Compliance & Privacy, Cordis Corp, a Johnson & Johnson Co, Bridgewater NJ
Gregg H. Vicinanza Esq, Assoc General Counsel, Becton, Dickinson & Co, Franklin Lakes NJ
CO-CHAIRS:
Ted Acosta Esq, Principal, Ernst & Young LLP, Former Sr Counsel, Office of Inspector General, US DHHS, New York NY & Paris France
Link Bonforte, President, LB1 Consulting LLC, Former VP, Ethics & Compliance, ConvaTec, Belle Mead NJ
Sujata T. Dayal, Corp VP & Chief Compliance Officer, Global Operations, Biomet Inc, Warsaw IN
Doug Mowen, Managing Dir Medical Device Industry Lead, PricewaterhouseCoopers, Florham Park NJ
Kristine A. Rapp Esq, VP Global Ethics & Compliance, Hospira Inc, Lake Forest IL
TIME IS NOW FOR NEW, EFFICIENT & COST EFFECTIVE ALTERNATIVES TO TRADITIONAL LEARNING APPROACHES:
A variety of forces - the nation's economic crisis, costly and difficult air travel, the mandate for cost efficiency in healthcare, the proliferation of greater Internet bandwidth, the emergence of the popularity of online video via You Tube, and the explosion of online training in the health sector - has come together to create both a dramatic need and an extraordinary opportunity for innovative approaches to sharing new ideas and best practices. This Symposium offers not only traditional conference attendance, but also the opportunity to attend the event live and archived online. How can we be expected to reform the nation's health system if we can not reform the way we do our own business?
ATTENDANCE OPTIONS:
TRADITIONAL ONSITE ATTENDANCE
Simply register, travel to the conference city and attend in person. Pros: subject matter immersion; professional networking opportunities; faculty interaction
LIVE & ARCHIVED INTERNET ATTENDANCE
Watch the conference in live streaming video over the Internet and at your convenience at any time 24/7 for 6 months following the event. The archived conference includes speaker videos and coordinated PowerPoint presentations. Pros: Live digital feed and 24/7 Internet access for next 6 months; accessible in office, at home or anywhere worldwide with Internet access; avoid travel expense and hassle - no time away from the office.
CONGRESS EXHIBIT & SPONSORSHIP INFO:
For sponsorship & exhibit information, visit:
http://www.devicecongress.com/promotional/index.html
CONGRESS REGISTRATION INFO:
http://www.devicecongress.com/registration.html
registration@hcconferences.com
800-684-4549 phone
REGISTER BY FRIDAY OCT 9 FOR EARLY BIRD DISCOUNT:
http://www.devicecongress.com/registration.html
SOURCE:
Medical Device Compliance Congress
http://www.devicecongress.com
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09-28-2009 : Global Congress Of Maternal & Infant Health Planned For Barcelona Spain; Early registration deadline is Nov 30 2009
GLOBAL CONGRESS OF MATERNAL & INFANT HEALTH PLANNED FOR BARCELONA SPAIN
-- Early registration deadline is Nov 30 2009
-- Sept 22-26 2010 -- Barcelona Spain
http://www.globalcongress2010.com
Barcelona Spain -- Medical Industry E-Mail News™ -- Sept 28 2009 -- Matres Mundi announced details today of its upcoming Global Congress Of Maternal & Infant Health to be held next year in beautiful Barcelona Spain, on Sept 22-26 2010.
BACKGROUND:
This event will be a milestone in the history of perinatal medicine, because: First, the most important opinion leaders on maternal and infant health around the world are in the faculty of the congress. Scientific experts form over 80 countries on 5 continents will be in Barcelona to share knowledge and expertise on relevant topics and novel aspects in the field. For a few days, Barcelona will be the capital of the world perinatal medicine. A great effort has been made to present a program with a balanced content, including research, clinical practice, daily problems and future perspectives.
Second, Congress organizers have been particularly concerned regarding the huge differences in medical care needs in reproductive medicine worldwide, cultural diversities, and the very unfortunate reality that modern medicine is a privileged resource for a few. For this reason, the key words of this Congress are globality, dialogue and solidarity. Globality, because the meeting program includes participants from developed and developing countries, plus not only professionals in maternal and infant health, but also sociologists, social workers, politicians and others. All international scientific societies of perinatal medicine, nongovernmental organizations and international agencies involved in the field, will actively take part in the Congress activities.
REGISTRATION RATES & DETAILS:
Early Registration Deadline for lowest registration fee is Nov 30 2009
Abstracts Deadline for receipt of abstract submission is May 31 2010
Normal Registration Closing Date is July 31 2010
Late Registration Closing Date is at the Congress
Global Congress Opening Ceremony Sept 22 2010
ABOUT THE LOCATION:
Venue: alau de Congresos de Barcelona (Avda. M. Cristina s/n)
Barcelona is one of the most beautiful, fashionable and attractive cities worldwide. It has the ideal framework for this outstanding event, not only from the richness of its artistic, cultural and architectural perspective, but due to one of the best, modern and fully technically-equipped congress palaces in Europe being there. Hosts will do their best to ensure an unforgettable experience.
TO REGISTER:
REASONS TO ATTEND & SPECIFIC CHARACTERISTICS:
Thanks to Matres Mundi’s initiative, on these last years it has been possible to keep constant reunions among the institutions and people concerned with mother and infant health in the world. Consequently the Congress organization was born; its first edition will take place in Barcelona-Spain in Sept 22-26 2010, organized by Matres Mundi.
This Congress will include a reunion, which will be attended by an important group of high-level leaders in perinatal medicine. The dramatic situation of mothers and children in the poorest countries will be specially emphasized, since Matres Mundi feels there are more reasons than just cultural diversity, like example precarious conditions for maternity in so many countries in the world. This is why important discussions on solidarity are planned, to help the most unprotected of maternities.
The idea behind the Congress is to bring together all of the International Perinatal societies, NGOs and professionals involved in the reproductive process (obstetricians, neonatologists, midwives, nurses, epidemiologists, anthropologists, sociologists, etc). Representatives from all countries, particularly from those less scientifically advanced, are invited, so as to establish a worldwide dialogue that will steer the course of maternal and infant health everywhere. It is foreseen to plan future Congresses with a frequency to be later decided.
WHY THIS CONGRESS IS BEING HELD:
The situation of maternity between continents is absolutely different, and not only as a consequence of the cultural contrast, but especially as a result of financial inequalities. While maternal mortality in the prosperous countries of the Occident is almost irrelevant (20 per 100,000 live births), in the developing countries of Africa, Asia and Latin America, it is 300-900 per 100,000 live births.
The same occurs with neonatal and infant mortality. The first is 10 times greater in the developing countries than in the western developed countries. As far as the infant mortality is concerned, every year, 11 mln children die in the developing countries, due to illnesses that are perfectly curable in Europe or America.
In constrast the situation of women in some of the Eastern countries is very negative, with economic deficits (70% of the poor are women), cultural deficits (90% of the illiterate are women) and social deficits, including:
500 mln women suffer some kind of violence every year
130 mln suffer genital mutilation
6 mln are starving
3 mln adolescents are forced to become prostitutes in such conditions that their life expectancy is only 25 yrs
The efforts up to now that have been developed by international organizations (UN & its specialized agencies, World Bank, NGOs, etc.) have produced very poor results. Even the socioeconomic and sanitary situation of some of these countries has worsened in the last decade.
FACULTY: PRELIMINARY INVITED LIST OF MORE THAN 250 TOP SPEAKERS & EXPERTS:
CONGRESS HONORARY PRESIDENTS
Erich Saling (Germany)
Hiroshi Nishida (Japan)
Roberto Romero (USA)
CONGRESS PRESIDENTS
Jose M. Carrera (Spain)
Luis Cabero (Spain)
VICE-PRESIDENTS
Manuel G. Carrapato (Portugal)
Ernesto Fabre (Spain)
Vicente Cararach (Spain)
SECRETARY GENERAL
Javier Carbonell (Spain)
CHAIRMAN OF INTERNATIONAL SCIENTIFIC COMMITTEE
Frank Chervenak (USA)
CHAIRMAN OF INTERNATIONAL ADVISORY COMMITTEE
Asim Kurjak (Croatia)
CHAIRMAN OF INTERNATIONAL RELATIONS COMMITTEE
Jose M. Bajo Arenas (Spain)
CHAIRMAN OF INTERNATIONAL EDUCATIONAL COMMITTEE
Gian Carlo Di Renzo (Italy)
CHAIRMAN OF LOCAL ORGANIZING COMMITTEE
J.B. Lopez-Sastre (Spain)
CHAIRMAN OF SCIENTIFIC ORGANIZING COMMITTEE
Vicente Molina (Spain)
AUSPICATED BY:
Academia de Ciencias Medicas y de la Salud de Catalunya y Baleares
American Society for Maternal & Fetal Medicine (SMFM)
European Association of Perinatal Medicine (EAPM)
Federacion Latino Americana de Asociacion de Medicina Perinatal
Federation of Asia & Oceania Perinatal Societies
Ian Donald School of Ultrasonography
Intl Academy of Perinatal Medicine (IAPM)
Intl Society of “The Fetus as a Patient”
Matres Mundi International
Real Academia de Medicina de Catalunya
Sociedad Catalana de Obstetricia y Ginecologia (SCOG)
Sociedad Catalana de Pediatria (SCP)
Sociedad Espanola de Neonatologia (SEN)
Sociedad Espanola de Obstetricia i Ginecologia (SEGO)
Sociedad Espanola de Pediatria (SEP)
SCIENTIFIC PROGRAM: ISSUES ON MATERNAL & INFANT HEALTH
3-D Ultrasonography
Advances in Diabetes an Pregnancy
Advances in Intrauterine Growth Restriction
Advances in Multiple Pregnancy
Advances in Neonatal Ventilatory Therapies
Advances in Neonatal Veuroimaging
Advances in Perinatal Infections
Advances in Pre-eclampsia
Advances in Preterm Delivery
Advances in Therapy of Fetal Distress
Assisted Reproduction, its impact on Perinatal Medicine
Breast Feedings in Neonatal Risk Populations
Caesarean Section: Restricted vs Liberal use
Cervical Length Assessment & Premature Delivery
Changing Etiologies of Neonatal Death & Quality of Care Procedures
Changing strategies to treat & improve outcome of ELBW infants
Child Birth: Home birth vs Hospital birth
Cost Benefit in Perinatal Medicine
Dismorphology for Perinatologists
Doppler in Perinatology
Drug Addiction in Pregnancy
Early Pregnancy Loses
Embryo, Fetal & Neonatal Necropsy
Environment & Neonatal Care
Ethical issues in Perinatal Medicine
Evidenced-Based Medicine in Perinatology
Fetal Cells in Maternal Circulation
Fetal Therapy
Feto-Fetal Transfusion: Laser vs Amnio-drainage
Genetic Diagnosis & Future
Genetic, Maternal Infection & Brain Damage
Internet in Perinatology
Intrapartum surveillance: Cardiotocography vs Pulsioximetry
Management & Outcome of IUGR Infants updated
Managing Multiple Pregnancy: State of the Art
Markers of Pre-eclampsia Risk
Maternal Mortality. World perspective. What to do?
Maternity & Intl Cooperation
Maternity in Developing countries
Minimal Care for Healthy Newborns
Multiple pregnancy: Reproductive aspects vs Perinatal aspects
Necrotizing Enterocolitis prevention: Early vs late enteral nutrition
Neonatal Oncology
Neonatal Oxigenation: Pharmacologic vs Nonpharmacologic treatment
Neonatology in Developing countries
Nosocomial Infections in Neonatal ICU
Nuchal Translucency & Biochemical Screening
Nutrition in Mother & Infant
Outcomes of the Very-Low-Birth Weight Baby
Parenteral Nutrition & Enteral Dietary Supplements
Perinatal Asphyxia. Update Management of Hypoxia
Perinatal Endocrinology
Perinatal Hematology
Perinatal Health: World perspective. What to do?
Perinatal HIV. World situation
Perinatal Infections Updated
Perinatal Nutrition
Perinatal Pain (Mother, Fetus & Newborn)
Perinatal Quality Indicators & Perinatal Audit
Perinatal Rh Haemolytic Disease
Perinatal Transport
Persistent Neonatal Pulmonar Hypertension
Position in Labor
Preconceptional Counselling
Premature Rupture of Membranes: State of the Art
Prenatal Diagnosis: Biochemical screening vs Ultrasonographic screening
Preterm birth: Ultrasonographic Screening vs IV IgG
Preterm & Term Jaundice Newborn
Reproduction Techniques & Congenital Defects
Screening Procedures in Perinatology
Stem Cells from Cord Blood
Structure of Perinatal Care System: Present & Future Challenges
Teenage Births. Medicosocial Risks
Training in Perinatology
Ultrasonographic Diagnosis of Congenital Defects
Update Management of Hypoxicschemic Term Infants
Ventilatory Therapies & Surfactant
SCIENTIFIC PROGRAM: ISSUES ON SOCIAL PROBLEMS
Aggressions against infancy
Aggressions against women
Childbirth as a cultural phenomenon
Domestic violence
Fertility: # of children per woman
Genital mutilations
Inefficient sanitary systems
Infantile prostitution
Lack of sanitary resources
Legal & illegal abortion
Life expectancy at birth
Maternal mortality in developing countries
Perinatal & infantile mortality in developing countries
Relationship between per capita income & perinatal results
Rights of mother & newborn
Role of the NGOs
Role of UN specialized agencies
Situation of Perinatal Medicine in the World
SOURCE:
http://www.globalcongress2010.com
SCIENTIFIC SECRETARIAT MATRES MUNDI
TECHNICAL SECRETARIAT GRUPO PACIFIO, Congress Div
Calle Mariano Cubi 4 - Pral
08006 Barcelona Spain
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09-25-2009 : Drug Information Association (DIA) to Host Clinical Drug Development Forum; Oct 19-21
Drug Information Association 3rd Annual Clinical Forum:
NEW IDEAS, INTERFACES & DATA STREAMS TO ACHIEVE OPTIMAL PERFORMANCE & EFFICIENCY IN
CLINICAL DRUG DEVELOPMENT
http://www.diahome.org
-- Tracks Include: CDM, Clinical Research, Post-Marketing Development, Drug Safety, Quality Assurance, Validation
-- Oct 19-21 2009 -- Nice France
Basel Switzerland -- Medical Industry E-Mail News™ -- Sept 25 2009 -- The Drug Information Association (DIA) in Europe will host the 3rd Annual Clinical Forum: Improving Clinical Development Together, Oct 19-21 2009 in Nice France.
Multidisciplinary tracks and workshops will cover hot topics in clinical drug development with a special emphasis on the practical aspects of non-interventional studies, trials with adaptive designs, trials with drugs for personalized treatment and possibilities to increase the efficiency of the industry.
Tracks will Include:
CDM, eClinical, Clinical Research, Post-Marketing Development, Drug Safety, Quality Assurance
Validation
Medical Information & Communications
Medical Writing
Statistics
The 3rd Annual Clinical Forum also offers delegates the opportunity to generate new clients from one-on-one discussions with speakers, exhibitors and fellow delegates from various industry sectors and 20 countries, to explore the latest technologies on the exhibit floor and to build business relationships and expand professional contacts.
Networking Dinner: Tues Oct 20 2009; 19:00
Delegates can attend a seated dinner at the Grand Hotel Aston, an impressive 1928 building located on the Massena Square.
Exhibits:
The exhibit hall provides an opportunity to interact with a truly global audience of qualified professionals, from entry level to expert, in the pharmaceutical, biotech and related industries, government, academia and healthcare delivery. More than 30 exhibitors will showcase their products and services to over 400 key decision makers.
"This year's Clinical Forum will respond to the current need for bundling forces, sharing knowledge and experience and creating practical ideas together in these challenging times for drug development," says Program Chairperson Ingrid Klingmann, President, Pharmaplex bvba, Belgium. "You will find topics of great interest and relevance to you within your own professional area and related areas, helping you to better understand your colleagues' needs and common interests."
Click here to register
Click here to exhibit
About the Drug Information Association (DIA):
DIA serves more than 30,000 professionals involved in the biopharmaceutical industry and regulatory affairs worldwide. Through its domestic and international meetings, training courses, workshops and webinars, DIA provides a neutral global forum for the exchange of information critical to the advancement of the drug discovery and lifecycle management processes. Headquartered in Horsham PA USA, and with offices in Basel Switzerland, Tokyo Japan, Mumbai India, and Beijing China, the Association is led by its volunteer-based Board of Directors and executive management team.
SOURCE:
Drug Information Association
800 Enterprise Rd Ste 200
Horsham PA USA 19044
http://www.diahome.org
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09-24-2009 : Dr. Danny Bluestein, Bioengineering Hemodynamics Expert, Joins MicroMed Science Advisory Board
DR. DANNY BLUESTEIN JOINS MICROMED SCIENCE ADVISORY BOARD
-- Professor of Bioengineering at SUNY-Stony Brook is Leading Expert in Hemodynamics
http://www.micromedcv.com
Houston TX USA -- Medical Industry E-Mail News™ -- Sept 24 2009 -- MicroMed Cardiovascular announced today that Danny Bluestein, PhD, Professor of Bioengineering at SUNY-Stony Brook, has joined the Science Advisory Board (SAB) to provide industry expertise and guidance for the HeartAssist 5™ ventricular assist device, the Modern DeBakey VAD™.
“Dr. Bluestein is a leading edge researcher in biofluids and the dynamics of blood flow in the cardiovascular system,” said Bill Birdsall, CEO of MicroMed. “He brings valuable expertise to the SAB in hemodynamics, flow induced cardiovascular pathologies and design optimization of cardiovascular prostheses, including ventricular assist devices.”
Dr. Bluestein is an established investigator for the American Heart Association and the Director of the Biofluids Laboratory at SUNY-Stony Brook. He is currently conducting research on the formation of thromboemboli in cardiovascular devices using innovative in vitro techniques and platelet assays, Computational Fluid Dynamics (CFD), Fluid Structure Interaction (FSI) modeling and Digital Particle Image Velocimetry (DPIV).
Dr. Bluestein joins other world-renowned members of MicroMed's SAB, including transplant surgeon George Noon MD, co-inventor of the HeartAssist 5, Dr. Marvin Slepian, Director of Interventional Cardiology at the University of Arizona and Matthias Loebe, MD, PhD, professor at Baylor College of Medicine in Texas.
The HeartAssist 5 pump weighs only 92 grams and measures just 2.8 x 1.2 inches. Because of its miniature size, it is one of the few LVADs that can be implanted above the diaphragm, adjacent to the heart. The HeartAssist 5 is the only LVAD with a precise, direct flow measurement system. Unlike other devices, blood flow for the HeartAssist 5 is a precise measurement and does not rely on estimates by software or the clinician.
In Europe, the HeartAssist 5™, the Modern DeBakey VAD™, has CE Marks for both adult and pediatric use. In the U.S., the HeartAssist 5, formerly DeBakey VAD® Child, is the only FDA-approved pediatric VAD. A bridge-to-transplant IDE clinical study is currently underway in the U.S. for adults.
SOURCE:
MicroMed Cardiovascular
8965 Interchange Dr
Houston TX USA 77054
http://www.micromedcv.com
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09-24-2009 : Newt Gingrich, Dr. Sanjay Gupta, Michael Moore at HealthAchieve 2009 Conference & Exhibition; Nov 16-18 2009, Toronto Canada
HEALTHACHIEVE 2009: A "MUST-ATTEND" EVENT FOR HEALTH CARE LEADERS -- Nov 16-18 2009 -- Metro Toronto Convention Centre, Toronto Ont Canada
-- Over 9,000 health care professionals looking for the latest, cutting edge technology set to transform future health care delivery
http://www.healthachieve.com
Toronto Ont Canada -- Medical Industry E-Mail News™ -- Sept 24 2009 -- Winner of some of the most prestigious awards for its industry, HealthAchieve has secured its position as a must attend event for leaders in today's health care environment, organizers announced today for the Nov 16-18 2009 event.
HIGH PROFILE AWARDS PROVE HEALTHACHIEVE IS A TOP-NOTCH EVENT:
HealthAchieve, a world-class showcase of ideas and innovations in health care, took home the Best Trade Show Award at this year's Annual Canadian Event Perspective Magazine Star Awards (a national program which recognizes outstanding achievements in Canadian special events)
HealthAchieve also won a total of eight awards in 2008 among various categories at the International Association of Exhibitions and Events (IAEE) Art of Show Competition, which recognizes excellence in promotional materials for the exhibitions and events industry.
In addition, Isabella Wai, HealthAchieve's Director of Convention Exhibits, received the 2008 Canadian Association of Exposition Management (CAEM) Member of the Year Award. This award is given to individuals who have dedicated their careers in advancing the exposition industry and for outstanding volunteer contribution to the CAEM over the past year.
HealthAchieve has become the largest event of its kind in Canada, and it continues to grow, attracting more than 9,000 health care professionals and over 350 exhibiting companies from across Canada and beyond. HealthAchieve provides a cutting-edge showcase of the latest innovations in technology, offers dynamic learning opportunities and allows for networking among today's top health care and business leaders.
GET INVOLVED IN ONE OF TODAY'S MOST PROGRESSIVE HEALTH CARE EVENTS:
EXHIBIT -- An exhibit space at HealthAchieve allows you to meet some of the hardest to reach people in the industry, generating unprecedented awareness of your products and services while building relationships with some of the best and brightest minds in health care.
SPONSOR -- With a HealthAchieve sponsorship package, you can maximize the visibility of your organization. Whether your goal is to create awareness, generate sales, position a product or service, or demonstrate corporate responsibility, HealthAchieve can ensure you reach your target audience. Sponsor a keynote session, a special area on the Exhibit Floor, a special event, or create a unique sponsorship opportunity to suit your needs. HealthAchieve can work with you to explore the best ways to achieve your goals.
ADVERTISE -- No other convention and exhibition delivers an audience of over 9,000 leaders from the health care field, primarily from Ontario but also nationwide and internationally. Advertising in any number of HealthAchieve's promotional and show materials will help you make the strongest possible connection with health care audiences from all over the globe.
WHAT EXHIBITORS SAY ABOUT HEALTHACHIEVE:
"HealthAchieve is THE Canadian trade show for reaching decision makers in the health services sector."
-- Kent Waddington, Canadian Coalition for Green Health Care
"This was a tremendous platform for the Canadian launch of our company."
-- Patrice Shennette, Optimum Sciences Inc.
Hear what exhibitors are saying about HealthAchieve
Program Highlights
More about exhibiting, sponsorship & advertising
See which exhibit spaces are still available
For more information on exhibit space rates & reservation information
Exhibit, Sponsorship & Advertising Prospectus
Sponsorship Opportunities
Exhibition Information
For exhibitor information, contact Isabella Wai at 416-205-1354 or iwai@oha.com
For sponsorship and advertising opportunities, contact Kumarie Perera at 416-205-1381 or kperera@oha.com
HEALTHACHIEVE2009 WILL FEATURE KEYNOTE ADDRESSES BY:
-- Dr. Sanjay Gupta, Chief Medical Correspondent for CNN
-- Michael Moore, Academy Award Winning Documentarian and Best-Selling Author
-- Richard Florida, Renowned Economist and Author
-- Newt Gingrich, Conservative Political Visionary and Thought Leader
and many more...
MORE ABOUT HEALTHACHIEVE:
VENUE: Metro Toronto Convention Centre, Toronto Ont Canada
DATES: Nov 16, 17 & 18 2009
PROGRAM HIGHLIGHT
REGISTRATION
FULL INFORMATION
SOURCE:
HealthAchieve2009
200 Front St W Ste 2800
Toronto Ont M5V 3L1 Canada
http://www.healthachieve.com
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09-23-2009 : 4th Annual Orthopedic Design & Technology Conference & Exhibition, Oct 6-8 2009
4th ANNUAL ORTHOPEDIC DESIGN & TECHNOLOGY CONFERENCE & EXHIBITION ANNOUNCED
http://www.odtexpo.com
-- Oct 6-8 2009 -- Grand Wayne Convention Center, Ft Wayne IN USA
-- Speakers To Include: Super Bowl Champ Leonard Marshall & Kevin Scott MD, Surgical Director, Laser Spine Institute
-- Register by 9/30, save $100 off Registration; Complimentary Admission for Qualified OEMs
Ramsey NJ USA -- Medical Industry E-Mail News™ -- Sept 23 2009 -- Orthopedic Design & Technology Magazine is hosting its 4th Annual Conference & Exhibition, to be held Oct 6-8 2009 at the newly renovated Grand Wayne Convention Center, Ft Wayne IN.
More than 400 attendees and 80 exhibitors are expected to attend. Registration is complimentary for qualified OEMs and nominal for suppliers.
To Register: http://www.odtexpo.com
Who Should Attend:
Finished Goods Manufacturers
OEMs
Contract Manufacturers
Suppliers
Service Companies Who Supply the Orthopedic Market
Sessions Include:
Is the US Behind the Innovation Eight Ball? Unmet Market Needs & New Opportunities for Technology
-- Robin R. Young, CFA, Founder/President, RRY Publications
Panel Discussion -- Understanding How the Pressures of Perfect Prototyping Is Changing the Rules of Manufacturing
-- H W "Andy" Anderson, Dir of Operations, Wenzel Spine Inc
-- Jonathan Blocker, Account Mgr, Orchid Orthopedic Solutions
-- Peter Browne, Sales Engineer, FMI Medical Instruments
-- Mark Michael, President/COO, Ft Wayne Metals
Panel Discussion -- Utilizing Advanced Technology for Improved Product Development: Considerations for Selecting an Effective Software Solution
-- Nikki Willett, VP of Marketing & Regulatory Affairs, Pilgrim Software
-- Linda L.S. Lovett, Medical Device Consultant
Making the Right Strategic Outsourcing Decisions: A Contract Manufacturing Status Report
-- Rod Wilson, Dir of US Procurement, DePuy Orthopedics
Biocompatibility & Testing: Planning Ahead for a Streamlined Process
-- Dave Parente, Sr Consulting/GM, NAMSA Consulting
Supply Chain Management in a Complex Global Environment
-- Gerard J. Pearce, Exec VP, SQA Services
Panel Discussion -- Policy Changes Affecting Regulatory Affairs Compliance
-- James Ravitz, Partner, Arent Fox PLLC
-- Jeffrey Dow Esq, Regulatory Affairs Mgr, Synthes Inc
-- Julie Dykstra, Barnes & Thornburg LLP
Surgeon Meets Supplier: Realities of the Progress We've Made in Technology Advancements
-- Kevin Scott MD, Surgical & Medical Director, Laser Spine Institute
Raise Money, Partner or M&A: Now That You Have Designed Your Device, What Are Your Options?
-- Timothy Schmidt, VP, Capstone Partners LLC
When the Chariot Stops: Medical Mayhem of a Retired NFL Player
-- Leonard Marshall, Exec Dir, Game Plan Foundation & 2 Time Super Bowl Champion; Author/Professor, Seton Hall University
GOLD SPONSORS
-- Autocam Medical
-- Ft Wayne Metals
-- Micron Integrated Technologies
-- Symmetry Medical
SILVER SPONSORS
-- Orchid Orthopedics
BRONZE SPONSORS
-- Astro Medical Devices
-- FMI Medical Instruments
-- Northeast Indiana Regional Partnership
-- Triangle Manufacturing
SOURCE:
Rodman Publishing
http://www.rodpub.com
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09-22-2009 : Total Artificial Heart Manufacturer SynCardia Announces Exclusive Licensing Agreement for AorTech Polymer Heart Valve
TOTAL ARTIFICIAL HEART MANUFACTURER SYNCARDIA ANNOUNCES
EXCLUSIVE LICENSING AGREEMENT FOR AORTECH POLYMER HEART VALVE
-- Elast-Eon™ Valve Anticipated to Lengthen Discharge Driver Battery Life and Result in Quieter Operation
http://www.syncardia.com
Tucson AZ USA -- Medical Industry E-Mail News™ -- Sept 22 2009 -- SynCardia Systems, Inc., manufacturer of the SynCardia temporary CardioWest™ Total Artificial Heart, has announced an exclusive technology licensing agreement with AorTech International plc (AIM: AOR). This agreement licenses the use of AorTech's Elast-Eon™ polymer heart valve (PHV) in the Total Artificial Heart, as well as SynCardia's future family of pulsatile products.
"The Total Artificial Heart is the only device that eliminates biventricular heart failure by replacing both failing ventricles," said Michael Gaul, SynCardia Chief Operating Officer. "The Elast-Eon PHV is designed to provide reliable support for patients who need the Total Artificial Heart as their Bridge To Life™."
"Our polymer heart valve has been tested extensively and has satisfied FDA pre-requisites for human use," said Frank Maguire, AorTech Chief Executive Officer. "The valve has been shown to have durability superior to that of biologic valves and comparable hemodynamic characteristics. In these studies, it has consistently demonstrated freedom from calcification and thrombus formation."
Due to its outstanding operating efficiency, the Elast-Eon valve requires less pressure and therefore less power to open and close. It is anticipated that the valve's efficiency will lengthen discharge driver battery life and result in quieter operation of the Total Artificial Heart, helping improve patient quality of life while they wait for a matching donor heart.
The license structure includes $2.1 million in fees payable over an 18 month period, minimum valve purchases and volume related discounts.
SynCardia anticipates animal studies later this year, with FDA and CE Mark submissions in 2H 2010.
About SynCardia Systems, Inc.
SynCardia Systems, Inc. is the Tucson-based manufacturer of the world's only FDA, Health Canada and CE approved Total Artificial Heart: the SynCardia temporary CardioWest™ Total Artificial Heart. There have been more than 800 implants of the Total Artificial Heart, accounting for more than 170 patient years of life on the device.
Originally used as a permanent replacement heart, the Total Artificial Heart is currently approved as a bridge-to-transplant for patients dying from end-stage, biventricular failure. The Total Artificial Heart is the only device that provides immediate, safe blood flow of up to 9.5 L/min through both ventricles.
For additional information, please visit:
http://www.syncardia.com
or follow SynCardia on Twitter: http://www.twitter.com/SynCardia_News
About AorTech International plc:
AorTech develops and manufactures biostable, implantable polymers, including Elast-Eon, the world's leading long-term implantable copolymer. With hundreds of thousands of successful long-term human implants, Elast-Eon is currently used in cardiology, orthopedic, urological and gastroenterological applications, including pacing leads, cardiac cannulae and stents. Devices manufactured from Elast-Eon have multiple US FDA PMA approvals, CE Marks and Japanese Ministry of Health approval.
Elast-Eon's biostability is comparable to silicone while exhibiting excellent mechanical, blood contacting and flex-fatigue properties. It can be processed using conventional thermoplastic extrusion and molding techniques. AorTech provides a range of materials in a variety of application-specific formulations for use in medical devices and components.
For additional information, please visit:
http://www.aortech.com
SOURCE:
SynCardia Systems, Inc.
SynCardia Systems Inc
1992 E Silverlake Rd
Tucson AZ USA 85713
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09-22-2009 : Biotech Supply Chain Conference For Marketing & Supply Chain Professionals To Feature 55 Top Speakers; South San Francisco CA
TOP 10 REASONS NOT TO MISS THE BIOTECH SUPPLY CHAIN CONFERENCE ANNOUNCED
http://www.biosupplyalliance.org/events.html
-- Rx For A Lean & Healthy Biotech Supply Chain - Only $395 (save $500), if register by Sept 30
-- Solutions for Marketing, R&D, Risk Mgmt, HR, Finance, Sales & Supply Chain Professionals
-- Oct 19-20 2009 -- South San Francisco Conference Center
Calabasas CA USA -- Medical Industry E-Mail News Service™ -- Sept 22 2009 -- The Biosupply Management Alliance (BSMA) announced new details today for its 2nd Annual Conference on profitability and growth, Rx For A Lean & Healthy Biotech Supply Chain.
The two-day conference includes over 55 top speakers who are key medical industry executives. The Oct 19-20 event is set for the South San Francisco Conference Center, in the popular northern California Bay Area. The Biosupply Management Alliance (BSMA) event provides a forum for collaboration, learning and best practices.
When & Where:
Oct 19-20 2009
South San Francisco Conference Center
South San Francisco CA USA
http://www.biosupplyalliance.org/events.html
devendra@biosupplyalliance.org
Registration & Program Info:
Only $395 for 2-day conference (save $500), if you register by Sept 30 2009.
http://www.biosupplyalliance.org/bscaregistration.html
Top 10 Presentations & Topics:
# 1 "The Biotech Industry: $ and Sense"
The biotech industry has thrived as a new drug incubator for big pharma companies, which have poured money into acquisitions and partnerships to build up their biotech product line. A worldwide authority will take stock of the economic performance and outlook of companies, products, technologies, investments, consolidations, competitive environment and governmental regulations.
-- Casey McGlynn, Partner, Wilson Sonsini Goodrich & Rosati
# 2 "Regulatory Influences in Biogenerics - The Next Generation"
Presentation of scientific and science policy issues for legislative, regulatory, public affairs, and communications initiatives involving the government, industry and research community. Effective collaboration practices with regulatory agencies in discovery, development and manufacture of biotech-based medicines.
-- Gillian R. Woollett, Chief Scientist, Engel & Novitt
# 3 "Why Collaborate in the Biotech Supply Chain?
Global competition to reach emerging markets, increased pressure on pricing and reimbursement, under-utilized capacity of large manufacturing facilities, and expensive stocks of inventory are all calling the biotech supply chain executive to action to unlock sustainable value. AMR Research will preview their first annual Healthcare Top 25 ranking.
-- Wayne McDonnell, Research Director, Health & Life Sciences, AMR Research
# 4 "Developing Careers in Supply Chain Management: A Blueprint"
Case study of the development of supply chain management talent at Intel and the practical search for professionals at a recruiting firm.
-- James R. Kellso, Sr Supply Chain Master, Intel
-- Adam Zak, Principal & Founder, Adam Zak Search Recruiter
# 5 "Building Blocks of A World-Class Distributor"
Distribution in the biopharm industry has expanded its services with extraordinary results. The information-driven service provider will highlight how customer-centricity can be achieved, while reducing costs and lead-time and improving asset use.
-- John Figueroa, President, McKesson US Pharmaceutical
# 6 "Single Point of Failure: 10 Laws of Risk Management in the Supply Chain"
Proven methodology and solutions for management of strategic, tactical and random vulnerabilities in end-to-end supply chains.
-- Gary Lynch, CISSP, Managing Director/Global Practice Leader Supply Chain Risk Mgmt Practice, Marsh
# 7 "Rx 360: Global QA for Suppliers"
A Deming-based industry initiative to develop operating standards, share data and create an independent supplier audit function to improve the efficiency, oversight and accountability of the biopharm supply chain, leading to standardization of best practices and establishment of world-class suppliers.
-- Martin VanTrieste, VP, Quality, Amgen
# 8 "Profiting From Lean Six Sigma in Biotech: Experiences of The Best"
A Case Study of the successful evolution of lean six sigma principles, from the automotive to discrete manufacturing to biotech, will be analyzed to demonstrate contribution to the bottom line.
-- Edgar Sur, Head of Operational Excellence
#9 "4Ts of Cold Chain: Technology, Tracking, Temperature-Controlled Transportation"
Innovations in cold chain to achieve lower cost temperature transportation from clinical and bulk to commercial areas.
-- Rodney Derifield, CEO/Founder, Envirocooler
# 10 "Panels Of Industry Executives & Academia"
Development of Career & Supply Chain Management Talent
Operations Management: Managing the Enterprise in Turbulent Times
Risk Management: Overcoming Strategic, Tactical & Random Vulnerabilities
Visibility in Supply Chains: Building the Holy Grail
Launch & Commercial Management: Overcoming the Achilles Heel
Global Virtual Biotech Network: Accessing The Best Of Breed
Distribution Agility, Alignment & Adaptability: Maximizing Patient Care
Cold Chain Distribution: Technology, Tracking, Temperature-Controlled Transportation
Flexible Manufacturing: Overcoming Industry Constraints
Clinical Trials Management: Trials, Tribulations & Triumphs
Network, Market, Learn & Share With Industry Executives & Academia:
Over 200 executives are expected from about 80 companies and universities. Over 55 speakers have been confirmed.
Further Details:
To Register: dotti@biosupplyalliance.org
Program: devendra@biosupplyalliance.org
Sponsorship: arleen@biosupplyalliance.org
About the Biosupply Management Alliance:
The Biosupply Management Alliance was created for the worldwide community of operations and supply chain management leaders and professionals in the biotech, biopharm and biomed device industries. Based in the San Francisco Bay Area, home to more than 600 bio firms, BSMA provides a forum for collaboration, learning and best practices.
SOURCE:
Biosupply Management Alliance
23681 Andorra
Calabasas CA USA 91302
http://www.biosupplyalliance.org/bscaregistration.html
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09-21-2009 : UC Irvine Center for Health Care Management & Policy Conference Features Expert Speakers From Britain, Canada, Germany & US
UC IRVINE THE MERAGE SCHOOL'S CENTER FOR HEALTH CARE MANAGEMENT & POLICY CONFERENCE ANNOUNCED
-- Comparative Effectiveness: Lessons From Abroad
-- Presented by The Paul Merage School of Business, UC Irvine
-- Expert speakers from Britain, Canada, Germany & US
-- Oct 01 2009 -- Beckman Center, Irvine CA USA (adjacent to UC Irvine campus)
http://merage.uci.edu/ResearchAndCenters/HealthCare/Content/Health-Care-Speaker-Series/159
Irvine CA USA -- Medical Industry E-Mail News™ -- Sept 21 2009 --The UC Irvine Center For Health Care Management & Policy at the Paul Merage School of Business announced further details today of its upcoming 1-day conference, Comparative Effectiveness: Lessons From Abroad set for Oct 01 2009.
The conference, part of a regular series, attracts senior management from health care organizations, the public sector, academics, and physician and nurse executives. Attendees have an opportunity to network and meet the speakers at a post-event reception.
Speakers from Britain, Canada, Germany and the US will share insights on their experience, and health care leaders from the US will assess the implications of a similar process in this country.
Focus:
This conference provides a unique venue for dialogue among private and public sector leaders on key issues facing the nation on health care reform. It will help to determine what the US can learn from other countries in using comparative effectiveness (CE) analysis to improve health care quality and efficiency.
Some observes have expressed concern that federal funding for CE research in the US may evolve from providing information to developing a centralized national coverage decision-making process. Can knowledge of the foreign experience with CE enable the US to develop a uniquely American solution that harvests the benefits of better information while preserving independent decision-making?
When & Where:
Date: Thurs Oct 01 2009
Conference: 8:30 am-4:30 pm
Reception: 4:30 pm-5:30 pm
Site:
Arnold & Mabel Beckman Center, Irvine
(adjacent to UC Irvine campus)
National Academies of Sciences & Engineering
100 Academy Dr
Irvine CA 92697
949-721-2200 Beckman Center phone
Driving Directions:
http://merage.uci.edu/go/directions
Register Today:
http://merage.uci.edu/ResearchAndCenters/HealthCare/Content/Health-Care-Speaker-Series/159
Space is limited (all available seating sells out each year)
$350 per person UCI Faculty, Staff & Alumni
$450 per person for all other registrations
About the Health Care Speaker Series:
The Distinguished Speaker Program offers an annual series of lectures featuring prominent policy-makers, scholars, journalists, and other opinion leaders who address some of the most pressing issues in healthcare today.
This lecture series was launched in 2001 with Paul Ellwood MD -- the "father of HMOs" and instrumental in forming federal health policy and reforming private sector systems -- asking a provocative question: "Does managed care need to be replaced?" In subsequent years, industry leaders such as John Wennberg MD, director of the Center for the Evaluative Clinical Sciences at the Dartmouth Medical School, John Calfee PhD, resident scholar of the American Enterprise Institute, and Robert Moffit PhD, director of Domestic Policy Studies for the Heritage Foundation joined the list of prominent speakers at this coveted event.
Who Should Attend:
Physicians and nurses in administrative positions, physicians in private, group or clinical practice
Presidents, CEOs, Trustees and senior management in provider and insurer organizations
Senior executives in pharmaceutical, medical device, biotech and other health care organizations who define strategy and policy
Employers who deal with the problem of ever-increasing health care costs while attempting to increase employee choice
Government officials who define and implement health policy
Conference Sponsors:
Kaiser Permanente
California HealthCare Foundation
Event Speakers:
Donald E. Bobo, Jr; Corporate VP, Health Valve Therapy, Edwards Lifesciences
Stirling Bryan MS PhD; Professor of Health Economics, University of British Columbia, Canada
Andrew Dillon; CEO, National Institute for Health & Clinical Excellence, Great Britain
Paul J. Feldstein PhD; Professor & Gumbiner Chair in Health Care Management, Paul Merage School of Business, University of California, Irvine
Marjorie Ginsburg MPH; Executive Director, Center for Health Care Decisions
Peter V. Lee JD; Executive Director, National Health Policy, Pacific Business Group on Health
Murray N. Ross PhD; VP, Kaiser Foundation Health Plan, Director, Kaiser Permanente Institute for Health Policy
Steven D. Pearson MD MSc FRCP; President, Institute for Clinical & Economic Review, Massachusetts General Hospital
Andrew J. Policano PhD; Dean, Paul Merage School of Business, University of California, Irvine
Jill Sanders PhD; President & CEO, Canadian Agency for Drugs & Technologies in Health, Canada
Peter Sawicki MD; Dir of Institute for Quality & Efficiency in Health Care, Germany
Sean Tunis MD MSc; Founder & Director, Center for Medical Technology Policy
Jill Yegian PhD; Dir of Health Insurance, California HealthCare Foundation
Topics Include:
US - Comparative Effectiveness & Health Policy -- This session will present an understanding of current policy and concerns, reform issues, quality and costs. Why is Comparative Effectiveness (CE) on the policy agenda? What is the difference between clinical CE and CE for health benefit coverage? Also discussed will be an understanding of CE analysis -- its usefulness and limitations.
How is Comparative Effectiveness Used Abroad -- Speakers from Britain, Germany and Canada will describe the use of CE in patient treatment decision-making.
Implications of Comparative Effectiveness for the Pharmaceutical, Provider, Payor Sectors & Patients -- Executives from these organizations will discuss the impact of developing a national capacity for Comparative Effectiveness research in the US Will it inevitably lead to payment and coverage decisions?
Advantages & Limitations of a Centralized National Capacity -- Speakers from Britain, Canada and Germany will discuss the issues with executives from pharmaceutical, provider, payor and patient organizations. What can be adopted from other countries and what will not work here? How do other countries handle the issues of innovation and R&D? How do other countries handle stakeholder perspectives and opposition?
Registration & Fees:
Only paid registrations will have a confirmed seat. Reservations by mail must be postmarked no later than Fri Sept 18 2009. After this date, only faxed registrations with credit card payment will be accepted. Registration fee is per person, includes all sessions, breakfast, lunch, coffee breaks, buffet reception and conference materials.
About The Paul Merage School Of Business:
The Paul Merage School of Business at UC Irvine offers four dynamic MBA programs -- plus PhD & undergraduate business degrees -- that deliver its thematic approach to business education: sustained growth through strategic innovation. We graduate leaders with the exceptional ability to help grow their organizations through strategic innovation -- supported by analytical decision-making, information technology and collaborative execution, and enhanced by a highly-personalized learning environment. In-class and onsite experiences with real-world business issues give our students the edge needed to help companies compete in today's global economy.
http://www.merage.uci.edu
While the Merage School is relatively young, it has quickly grown to consistently rank among the top 10% of all AACSB-accredited programs through exceptional student recruitment, world-class faculty, a strong alumni network and close individual and corporate relationships. The Merage School combines the academic strengths and best traditions of the University of California with the cutting-edge, entrepreneurial spirit of Orange County in the heart of America's Tech Coast.
In 2008, US News & World Report ranked the Merage School #44 in the US, while the Financial Times placed the School at #38 nationally, and #68 internationally. BusinessWeek placed the School within its Top 50 national listing and specifically ranks faculty research and publications at #20. During the past decade, the School has earned Top 10 rankings both nationally and internationally for its executive MBA program, faculty, curriculum components such as IT and marketing, recruitment services and overall value by such publications as the Financial Times, The Wall Street Journal, BusinessWeek and US News & World Report.
About The Center For Health Care Management & Policy:
The Center for Health Care Management & Policy serves as an interdisciplinary research institute that enables health care scholars, students, business leaders, policy experts, and professionals to share critical knowledge, research, trends, information and education. The Center is under the direction of Paul J. Feldstein PhD, Professor & Robert Gumbiner Chair in Health Care Management.
SOURCE:
Paul Merage School of Business, SB 431
University of California
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09-18-2009 : 2009 Medical Group Compensation & Financial Survey Now Available by American Medical Group Association
MEDICAL GROUP DATA FINDS FINANCIAL LOSSES IN MOST REGIONS
-- Average Increase in Physician Compensation for Most Specialties is Below 4%
-- 2009 Medical Group Compensation and Financial Survey Now Available
-- Compensation Continues To Fluctuate Only Marginally
-- Survey Includes Starting Salaries
http://www.amga.org
Alexandria VA USA -- Medical Industry E-Mail News™ -- Sept 18 2009 -- According to findings in the American Medical Group Association's 2009 Medical Group Compensation and Financial Survey, most specialties saw very modest increases in compensation in 2008, and many provider organizations continue to operate at a significant loss.
Average Compensation Increase of 3.5%:
The survey found that 81% of the specialties experienced increases in compensation in 2008, with the overall average increase around 3.5% (less than 2007, when 91% experienced an average increase around 3.5%). The primary care specialties (excluding hospitalists) saw about a 3.8% increase in 2008, while other medical and surgical specialties averaged around 6%. (The primary care specialties saw about a 3.2% increase in 2007, while other medical and surgical specialties averaged 3.7%).
The survey reports that during 2008, the specialties experiencing the largest increases in compensation were otolaryngology (8.63%), pathology (11.02%), and urgent care (7.33%).
For access to further details beyond this summary and to obtain full report visit: http://www.amga.org
Compensation Continues to Fluctuate Marginally:
"The survey indicates that compensation continues to fluctuate only marginally for most specialties," said Donald W. Fisher PhD, President/CEO of the American Medical Group Association (AMGA). "The modest increases seen this year reflect the negative impact of declining reimbursements, competition for specialists, the cost of new technology, and other factors on practice revenues in most parts of the country."
The section of the survey that examines financial operations found that medical groups in most regions continued to operate at a loss. In 2008, only organizations in the Eastern region were operating at break even. Organizations in the Southern region, which experienced significant losses in 2007 (median -$1,919 per physician), saw improvements, though they continued to operate as a loss (-$120 per physician).
Groups in the Northern region also continued to experience losses (-$3,254 per physician), despite improving performance (-$5,322 per physician in 2007). For the first time in five years, groups in the Western region reported they were operating at a loss (-$1,458 per physician), after being profitable in 2007 ($4,453 per physician).
Current Transaction-Based Reimbursement System is Largely Indifferent to Improvements by Medical Groups:
"In the face of the current economic climate, these medical groups continue to rise to the challenge of delivering the highest quality, coordinated care to the patients they serve," commented Fisher. "Most of the groups represented in the survey are large organized systems of care that make substantial investments in technology, operations, and the most innovative care processes to best serve populations under their care, and are able to achieve remarkable results for their patients. Our current transaction-based reimbursement system is largely indifferent to these results and to the efforts of medical groups to elevate the standard of care in the US. Currently AMGA is working to address the inequities of the current payment model as part of overall healthcare reforml and to develop a model that incorporates a substantial component reflecting achievement of quality results."
The AMGA 2008 Medical Group Compensation and Financial Survey gives a complete financial picture of medical group operations in one volume, providing compensation, productivity, and financial operations data from approximately 44,200 healthcare providers throughout the US. It includes 120 specialties, 29 other healthcare provider positions and 21 administrative positions.
Survey Data Includes Starting Salaries:
The survey data includes starting salaries by specialty; medians, means, and percentiles; compensation/productivity ratios; and comparative data from previous surveys, as well as providing analysis by group size and geographic region. In the financial section, profiles are provided per physician FTE, square footage and work RVU. In addition to staffing profiles, the financial data includes medians, capitation impact, accounts receivable analysis, and department level analysis. A section examines data specific to the academic/faculty practice environment. The 22nd annual AMGA compensation and financial survey was conducted by the national accounting firm of RSM McGladrey, Inc.
RSM McGladrey is a leading professional services firm providing accounting, tax and business consulting. RSM McGladrey operates in an alternative practice structure with McGladrey & Pullen LLP, a partner-owned CPA firm that delivers audit and attest services. Through separate and independent legal entities, they work together to serve clients' business needs. Together, the companies rank as the fifth largest US provider of accounting, tax and business consulting services (SOURCE: Accounting Today), with 8,000 professionals and associates in nearly 100 offices.
RSM McGladrey Inc. and McGladrey & Pullen LLP are member firms of RSM International, an affiliation of independent accounting and consulting firms. RSM McGladrey is the official accounting, tax and business consulting firm of The PGA of America. From accounting and tax to reimbursement and physician compensation services, our health care specialists deliver effective and affordable solutions to nearly 3,000 health care institutions across the nation.
The American Medical Group Association is an association that represents medical groups, including some of the nation's largest, most prestigious medical practices, independent practice associations, and integrated healthcare delivery systems. AMGA improves health care for patients by supporting multi-specialty medical groups and other organized systems of care. The members of AMGA deliver health care to approximately 96 mln patients in 49 states. Headquartered in Alexandria, Virginia, AMGA is the strategic partner for medical groups providing a comprehensive package of benefits, including political advocacy, educational and networking programs and publications, benchmarking data services, and financial and operations assistance.
To Order Your Own Copy:
Surveys are available for purchase for $295 to AMGA members and $590 to nonmembers. To order, visit http://www.amga.org or contact Stefan Rozga at 703-838-0033 ext 326. Survey data is also available in a subscription-based, interactive, online database. For details, contact Stefan Rozga or visit http://www.amga.org
SOURCE:
American Medical Group Association (AMGA)
Alexandria VA USA 22314-3403
http://www.amga.org
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09-17-2009 : Medical Device Companies To Partner With University Of Memphis To Recruit Employee-Students
MEDICAL DEVICE COMPANY PARTNERSHIP WITH THE UNIVERSITY OF MEMPHIS ANNOUNCED
-- Plan To Recruit Employee-Students By Providing A Full-Tuition Paid MBA
-- Program Includes: Stipend, Internship & Offer of Employment Through The Customer-Driven MBA Program
-- Students Can Apply Through December 2009 for the 2010 Program
http://www.memphis.edu/fcbe/cdmba_apply.php
Memphis TN USA -- Medical Industry E-Mail News™ -- Sept 17 2009 -- University of Memphis Fogelman College officials announced details today of a program that is specifically focused on the medical device manufacturing industry. Students who complete the program will be offered employment with sponsoring medical device companies at competitive salaries.
As top medical device companies are demanding more from their new employees, the firms are trying something different to recruit newcomers. Companies are now partnering with the University of Memphis to provide student recruits with a full-tuition-paid global MBA that encompasses a direct industry tract in the biomedical field.
Training For Managers At Mid-Level & Above:
The MBA program at the University of Memphis will focus on recruiting, educating and training managers at mid-level and above in globalized general business and specific medical industry subjects.
"Medical device companies require a skill set and knowledge-base from their employees that are very specific to the industry. It is essential for medical professionals to understand the regulatory pathway, product development cycles, and Medicare reimbursement, for example," says Barbara DeVivo, the MBA Marketing Director at the University of Memphis Fogelman College who has spent her career as a marketer in the medical device industry. "These topics are never taught in graduate school. The knowledge is acquired through years of exposure in the industry," DeVivo says.
Program Details:
The customer-driven MBA will provide prospective student-employees with an avenue to engage in a rigorous 21-month full-time, work-study MBA program, where they will learn core business subjects, industry specific knowledge, and corporate management through internships throughout the program.
In addition to these skills, the program will train students with the fundamentals in:
Governance & ethics
Emotional intelligence
Teamwork
Leadership
Critical thinking
Creativity
Innovation
Problem-solving
Part-Time Internships With Medical Device Companies:
A key component of the 21-month program will be part-time internships with the sponsoring medical device companies during the main academic years, September to May, and full-time during the summer. Additionally, students who successfully complete the program will be offered employment with their sponsoring companies at competitive salaries.
Plans call for the collaborating companies to support the program financially. Students will each receive tuition payment, plus a $36,000 stipend, for the duration of their enrollment.
Upon graduation, the MBA degree-holders will not only have broad and specific knowledge of business concepts, but will be familiar with the operations of their hiring companies. Thus, they can be even more valuable to the companies, and the companies will see a quicker return on their investments in the students.
History of Program Launch:
Dr. Rajiv Grover unveiled the new program at the Fogelman College of Business & Economics kickoff luncheon in May 2008. Dr. Grover, Dean of the Fogelman College, calls it "customer driven," because it will help answer a need for managers in local companies who are educated in the classic curriculum of an MBA program, as well as in certain disciplines that are particularly needed by those companies.
Recruitment:
Students will be recruited locally, nationally and internationally. The companies will be involved in selecting the students for acceptance into the program.
"Workforce development is a key concern of local business leaders, Grover said, and this program will address that concern. It will bring well-qualified employees into the local business community, and allow the companies and university to educate them with the right industry training, so they can be effective Day 1 post graduation," says Dr. Grover.
Embedded Knowledge:
In particular, "Knowledge of a company is what we call embedded knowledge," Grover explained. "It is the sort of thing that takes time for a new employee to learn. Graduates of this MBA program will go to work having that knowledge from their first day on the job. That will enable them to begin making significant contributions to their companies more quickly."
Customized Courses:
The biomedical track will offer four customized courses that have been developed with the help of top professionals in the medical device industry. These courses include health care economics, buyer (e.g., hospitals, surgeons) behavior, global supply chain management in the biomedical field, and new product development.
Additionally, the new program will call on the expertise of faculty members from throughout the University, and classes will also be co-taught by leading professionals in the community.
Dr. Grover characterizes the program as a "win-win-win" situation. "The University will get very good students. The students will get a very good education and on-the-job work experience virtually at no cost, in addition to a $36,000 stipend. The businesses involved will then get excellent workers who can make significant contributions to the company immediately."
Reviewing Candidates:
The University of Memphis Fogelman College of Business and its Biomedical Corporate Partners are currently reviewing candidates through Dec 2009 for the Fall 2010 entering class. An initial enrollment of about 10 students in the biomed track is expected. That number should increase, as the program gains prominence and knowledge of its existence spreads.
"We have been positively overwhelmed with the number of inquires coming in from interested students around the globe. The caliber of individuals that we are attracting is astonishing," says DeVivo. "We at the University look forward to placing these professionals with our Medical Device Corporate Sponsors much sooner than originally anticipated."
More Information Available at the University of Memphis Website:
http://www.customerdrivenmba.memphis.edu
To Apply:
To be considered for the program, please apply online below:
http://www.memphis.edu/fcbe/cdmba_apply.php
SOURCE:
Fogelman College of Business & Economics
http://www.customerdrivenmba.memphis.edu
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09-16-2009 : Noblitt & Rueland FDA Regulatory Training Seminar Early Registration Deadline is this Friday Sept 18; San Francisco Bay Area
5 REGULATORY TRAINING COURSES TO DISCUSS FDA ENFORCEMENT & INTL COMPLIANCE ISSUES IN SAN FRANCISCO BAY AREA
-- FDA cites training violations in 30% of Warning Letters -- see info bullet below for more details
-- Topics that have become top priority for FDA investigators & reviewers will be covered
along with key international compliance problems
-- Goal of training is to help companies avoid regulatory enforcement action & be more efficient in the process
-- Oct 26-30 2009 -- Embassy Suites on the San Francisco Bay, Burlingame CA USA
-- Early Registration Discount Ends This Friday Sept 18
http://www.fdatraining.com/trains.shtml
Irvine CA USA -- Medical Industry E-Mail News™-- Sept 16 2009 -- Noblitt & Rueland today announced further details of its comprehensive regulatory seminar schedule for Oct 2009. All events will be held at the Embassy Suites Hotel on the San Francisco Bay, Burlingame CA USA.
Topics that have become top priority for FDA reviewers and compliance inspectors will be covered, to help protect you and your company from severe regulatory enforcement action.
OCT COURSES: EMBASSY SUITES ON THE SAN FRANCISCO BAY, BURLINGAME CA (attend any 1 or more training programs)
Oct 26; Mon -- FDA Quality System Regulation (QSR/GMP) & FDA Inspections
Oct 27; Tue -- Auditing Quality Systems for FDA & ISO Compliance
Oct 28; Wed -- Design Control, the FDA & ISO
Oct 29; Thu -- Risk Management, ISO 14971 & FDA Requirements
Oct 30; Fri -- Software Verification & Validation Strategies
VENUE:
Embassy Suites on the San Francisco Bay, Burlingame CA USA Convenient to San Francisco Airports, Downtown San Francisco & Silicon Valley
Special course discounts, including multiple attendee discounts, are available. Early registration discount ends this Friday Sept 18.
Course Descriptions:
To Download A Seminar Brochure:
To Register:
For Registration & Hotel Info:
CRITICAL NEWS HIGHLIGHTS: FDA & ISO MEDICAL DEVICE HOT TOPICS:
FDA CITES TRAINING VIOLATIONS IN 30% OF WARNING LETTERS. The "Silver Sheet" published by Elsevier Business Intelligence recently published a special report revealing a significant increase in FDA citations regarding employee training violations. The number of Warning letters issued by FDA that cited training deficiencies jumped from 22% to 30% in 2008. Overall training programs are discussed, with QSR & Inspections, risk management & ISO 14971, design controls, 21 CFR Part 11, up-to-date training records, and the importance of auditing being specifically mentioned in the report. These topics and others will be discussed during the training program to be held Oct 26-30 in the San Francisco Bay Area, Burlingame CA.
NEW ADMINISTRATION in the White House and new FDA Commissioner means new direction for the FDA. Recent high profile cases and outside agency government reports indicate that additional QSR enforcement, oversight, more rigorous 510(k) reviews, and additional regulation are not just on the horizon, but are now happening. Below we discuss some of these activities and during our training we will be discussing the potential impact of all of these critical actions to medical device manufacturers.
FDA CHANGES POLICY ON WARNING LETTER REVIEWS. FDA is changing their program on the issuance of warning letters in an effort to facilitate the issuance of warning letters in a timelier manner. Beginning Sept 15, the adequacy of written responses by an inspected company to FDA 483 observations that are received within 15 days of the FDA 483 being issued will be considered in determining whether a warning letter should be issued. The adequacy of the 15 day response will also be recognized in the warning letter if it is issued. Reponses to FDA 483 observations received after 15 days will be reviewed along with other documents and information received in response to a warning letter when issued.
FDA QUALITY SYSTEM INSPECTION RESULTING IN 510(K) REVIEWS & POSSIBLE WITHDRAWS. A recent FDA quality system inspection of a company in southern California and the resulting Warning Letter comments suggest to the receiving company that it should review several previously cleared 510(k) applications and consider withdrawing the cleared applications, if the data is thought to be unreliable or unverifiable. Companies submitting 510(k)s need to be aware that data supporting the 510(k) may be investigated during your quality system inspection.
DESIGN CONTROL & SOFTWARE CONTINUE TO BE COMPLIANCE ISSUES BEING CITED IN FDA WARNING LETTERS. Companies have received warning letters for Design Control related issues including issues such as inadequate Software Verification & Validation for device, production, and quality system software; and Risk Management activities. Proper Risk Management activities and documentation have helped companies comply and demonstrate the adequacy of their Design Control activities.
510(k) PROGRAM MODIFICATIONS POSSIBLE. FDA's role or lack of oversight on manufacturer's decisions when deciding not to submit information to FDA regarding device modifications is being questioned by Senator Grassley of Iowa in a letter sent to the Acting FDA Commissioner and the overall 510(k) process is being reviewed. Manufacturers may be greatly impacted if the agency changes their current policy & guidance on 510(k)s and when to submit a new 510(k) for changes to a device.
LAST DAY TO DISTRIBUTE PRODUCT UNDER THE OLD VERSION OF THE MDD IS MARCH 21 2010. After that, all distributed product must comply with the 2007 revision of the MDD. The same date applies to the revision of the AIMDD. You have just approximately 7 months left to update all technical files and design dossiers. Although the installed base is not affected, there is no grandfathering for products distributed after March 21, 2010 (regardless of how long the version has been distributed previously in Europe). Please call or e-mail if you have questions or need assistance in complying and meeting the deadline.
ENFORCEMENT ACTIONS ARE VERY COSTLY. Judgments and enforcement actions by the FDA should motivate companies and their management to ensure that their companies are compliant with the Quality System (QS/GMP) regulations. Enforcement actions resulting from GMP/QS regulation violations have been very serious and have included consent decrees, $100+ mln & $500+ mln fines, corporate warning letters, injunctions to stop manufacturing due to QSR and Design Control issues, and international firms receiving import detention, etc. A recent US District court complaint against a US medical device manufacturer specifically cites inadequate quality system training of both employees and management in support of a seizure order.
SEVERITY OF ENFORCEMENT PENALTIES HAS INCREASED. Repeat offenders and management should beware of this worsening potential.
REQUIREMENT FOR INTERNAL AUDITING WHEN PERFORMED EFFECTIVELY HAS SAVED MANY COMPANIES BOTH ENFORCEMENT HEADACHES & PENALTIES. Companies have avoided negative competitive and investor relations by finding and correcting deficiencies prior to FDA inspections. These corrections have prevented FDA enforcement actions and Warning Letters from being issued, published on the Internet, and being available to competitors for distribution to customers. In addition, many companies have found that investors become nervous when FDA enforcement actions occur. Obviously, many times the firms experience a negative impact to their stock price or funding.
Program Brochure:
Course-Specific Info Includes a Brief Outline for Each Course:
Register Online Here:
or by fax at 714-258-3990.
FOR ADDITIONAL HOTEL & REGISTRATION INFO:
Printed brochures and registration are available by phone at 714-258-4646 or 888-892-4664 (in the US & Canada).
SOURCE:
Noblitt & Rueland
http://www.fdatraining.com/trains.shtml
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09-15-2009 : Complimentary Cardiology Webinar: Achieving Cardiac Rehab Excellence; Thur Sept 24 2009
UPCOMING COMPLIMENTARY WEBINAR: "ACHIEVING CARDIAC REHAB EXCELLENCE" -- SEPT 24 2009, 1 PM EASTERN STANDARD
-- Webinar Date: Thur Sept 24 2009 -- 10 AM Pacific, 12 Noon Central, 1 PM Eastern
-- Discover how a leading health system successfully aligned clinical goals with IT resources to deliver evidence-based, patient-centric care
-- Learn same strategies, technologies and best practices
http://www.lumedx.com/offers/Webcast_CardiacRehab_0909-pr/default.asp
Oakland CA USA -- Medical Industry E-Mail News™ -- Sept 15 2009 -- Details have been announced for the upcoming complimentary webinar -- Achieving Cardiac Rehab Excellence -- to be held online Thursday, Sept 24 2009.
Registrants signing up for the program will learn the strategies, technologies and best practices that Delaware-based Christiana Care Health System implemented to transform data management, streamline workflow, easily document outcomes and enhance patient satisfaction.
Among The Successes:
A physician referral rate of 97.2%
A patient enrollment rate of 64.6%
SIGNUP TODAY:
Achieving Cardiac Rehab Excellence will be held Thurs Sept 24 2009, at 10 AM Pacific, 12 Noon Central, 1 PM Eastern.
For more information and to register please visit (or paste the below URL in your browser):
http://www.lumedx.com/offers/Webcast_CardiacRehab_0909-pr/default.asp
GAIN THE KNOWLEDGE TO:
Design a faster yet more thorough and accurate data collection process, contributing to greater efficiency, quality of care and patient satisfaction
Create systems that easily document outcomes, supporting more informed decision-making and Pay for Performance initiatives
Streamline AACVPR certification
ESSENTIAL VIEWING:
Learn why a shared understanding of outcomes and the need for change helps focus, motivate and inspire both patients and clinicians.
The Achieving Cardiac Rehab Excellence webinar is essential viewing for heart centers looking for hands-on knowledge and field-tested experience in developing a successful program for ensuring quality care, promoting a positive patient experience, meeting Payer initiatives while managing costs.
FOR MORE INFORMATION VISIT:
http://www.lumedx.com/offers/Webcast_CardiacRehab_0909-pr/default.asp
Achieving Cardiac Rehab Excellence is part of the Success In CVIS Webinar Series, sponsored by LUMEDX Corporation.
SPEAKING OPPORTUNITIES:
For more information and regarding speaking opportunities, contact Randy Marc Lasnick, Director of Marketing, LUMEDX Corporation: rlasnick@lumedx.com or call 510-903-2092.
ABOUT LUMEDX:
With over 600 clients worldwide, LUMEDX is the market leader in fully integrated cardiology, thoracic surgery and vascular interventional radiology information systems, and the No. 1 independent integrator of cardiovascular information solutions. Our imaging and information solutions play a critical role in helping healthcare systems meet many of today's challenges and opportunities, including pay-for-performance, evidence-based medicine, greater competition and transparency in the marketplace, and new governmental regulations.
SOURCE:
LUMEDX Corporation
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09-14-2009 : UC Irvine Center for Health Care Mgmt & Policy Conference; Early-Bird Registration Ends Friday
UC IRVINE THE MERAGE SCHOOL'S CENTER FOR HEALTH CARE MANAGEMENT & POLICY CONFERENCE ANNOUNCED
-- Comparative Effectiveness: Lessons From Abroad
-- Presented by The Paul Merage School of Business, UC Irvine
-- Expert speakers from Britain, Canada, Germany & US
-- Sept 18 2009 -- Early bird registration deadline
-- Oct 01 2009 -- Beckman Center, Irvine CA USA (adjacent to UC Irvine campus)
http://merage.uci.edu/ResearchAndCenters/HealthCare/Content/Health-Care-Speaker-Series/159
Irvine CA USA -- Medical Industry E-Mail News™ -- Sept 14 2009 --The UC Irvine Center For Health Care Management & Policy at the Paul Merage School of Business announced details today of its upcoming 1-day conference, Comparative Effectiveness: Lessons From Abroad, set for Oct 01 2009.
The conference, part of a regular series, attracts senior management from health care organizations, the public sector, academics, and physician and nurse executives. Attendees have an opportunity to network and meet the speakers at a post-event reception.
Speakers from Britain, Canada, Germany and the US will share insights on their experience, and health care leaders from the US will assess the implications of a similar process in this country.
Focus:
This conference provides a unique venue for dialogue among private and public sector leaders on key issues facing the nation on health care reform. It will help to determine what the US can learn from other countries in using comparative effectiveness (CE) analysis to improve health care quality and efficiency.
Some observes have expressed concern that federal funding for CE research in the US may evolve from providing information to developing a centralized national coverage decision-making process. Can knowledge of the foreign experience with CE enable the US to develop a uniquely American solution that harvests the benefits of better information while preserving independent decision-making?
When & Where:
Date: Thurs Oct 01 2009
Conference: 8:30 am-4:30 pm
Reception: 4:30 pm-5:30 pm
Site:
Arnold & Mabel Beckman Center, Irvine
(adjacent to UC Irvine campus)
National Academies of Sciences & Engineering
100 Academy Dr
Irvine CA 92697
949-721-2200 Beckman Center phone
Driving Directions:
http://merage.uci.edu/go/directions
Register Today:
http://merage.uci.edu/ResearchAndCenters/HealthCare/Content/Health-Care-Speaker-Series/159
Space is limited (all available seating sells out each year)
$395 per person general public through Sept 18 2009
$350 per person UCI Faculty, Staff & Alumni
$450 per person after Sept 18 2009 for all registrations
About the Health Care Speaker Series:
The Distinguished Speaker Program offers an annual series of lectures featuring prominent policy-makers, scholars, journalists, and other opinion leaders who address some of the most pressing issues in healthcare today.
This lecture series was launched in 2001 with Paul Ellwood MD -- the "father of HMOs," and instrumental in forming federal health policy and reforming private sector systems -- asking a provocative question: "Does managed care need to be replaced?" In later years, industry leaders such as John Wennberg MD, Dir, Center for the Evaluative Clinical Sciences at Dartmouth Medical School; John Calfee PhD, resident scholar, American Enterprise Institute; and Robert Moffit PhD, Dir, Domestic Policy Studies for the Heritage Foundation; joined the list of prominent speakers at this coveted event.
Who Should Attend:
Physicians and nurses in administrative positions, physicians in private, group or clinical practice
Presidents, CEOs, trustees and senior management in provider and insurer organizations
Senior executives in pharmaceutical, medical device, biotech and other health care organizations who define strategy and policy
Employers who deal with the problem of ever-increasing health care costs while attempting to increase employee choice
Government officials who define and implement health policy
Conference Sponsors:
Kaiser Permanente
California HealthCare Foundation
Event Speakers:
Donald E. Bobo, Jr; Corporate VP, Health Valve Therapy, Edwards Lifesciences
Stirling Bryan MS PhD; Professor of Health Economics, University of British Columbia, Canada
Andrew Dillon; CEO, National Institute for Health & Clinical Excellence, Great Britain
Paul J. Feldstein PhD; Professor & Gumbiner Chair in Health Care Management, Paul Merage School of Business, UC Irvine
Marjorie Ginsburg MPH; Exec Director, Center for Health Care Decisions
Peter V. Lee JD; Exec Director, National Health Policy, Pacific Business Group on Health
Murray N. Ross PhD; VP, Kaiser Foundation Health Plan, Director, Kaiser Permanente Institute for Health Policy
Steven D. Pearson MD MSc FRCP; President, Institute for Clinical & Economic Review, Massachusetts General Hospital
Andrew J. Policano PhD; Dean, Paul Merage School of Business, UC Irvine
Jill Sanders PhD; President & CEO, Canadian Agency for Drugs & Technologies in Health, Canada
Peter Sawicki MD; Dir of Institute for Quality & Efficiency in Health Care, Germany
Sean Tunis MD MSc; Founder & Director, Center for Medical Technology Policy
Jill Yegian PhD; Dir of Health Insurance, California HealthCare Foundation
Topics Include:
US - Comparative Effectiveness & Health Policy -- This session will present an understanding of current policy and concerns, reform issues, quality and costs. Why is Comparative Effectiveness (CE) on the policy agenda? What is the difference between clinical CE and CE for health benefit coverage? Also discussed will be an understanding of CE analysis -- its usefulness and limitations.
How is Comparative Effectiveness Used Abroad -- Speakers from Britain, Germany and Canada will describe the use of CE in patient treatment decision-making.
Implications of Comparative Effectiveness for the Pharmaceutical, Provider, Payor Sectors & Patients -- Executives from these organizations will discuss the impact of developing a national capacity for Comparative Effectiveness research in the US Will it inevitably lead to payment and coverage decisions?
Advantages & Limitations of a Centralized National Capacity -- Speakers from Britain, Canada and Germany will discuss the issues with executives from pharmaceutical, provider, payor and patient organizations. What can be adopted from other countries and what will not work here? How do other countries handle the issues of innovation and R&D? How do other countries handle stakeholder perspectives and opposition?
Registration & Fees:
Only paid registrations will have a confirmed seat. Reservations by mail must be postmarked no later than Fri Sept 18 2009. After this date, only faxed registrations with credit card payment will be accepted. Registration fee is per person, includes all sessions, breakfast, lunch, coffee breaks, buffet reception and conference materials.
About The Paul Merage School Of Business:
The Paul Merage School of Business at UC Irvine offers four dynamic MBA programs -- plus PhD & undergraduate business degrees -- that deliver its thematic approach to business education: sustained growth through strategic innovation. We graduate leaders with the exceptional ability to help grow their organizations through strategic innovation -- supported by analytical decision-making, information technology and collaborative execution, and enhanced by a highly-personalized learning environment. In-class and onsite experiences with real-world business issues give our students the edge needed to help companies compete in today's global economy.
http://www.merage.uci.edu
While the Merage School is relatively young, it has quickly grown to consistently rank among the top 10% of all AACSB-accredited programs through exceptional student recruitment, world-class faculty, a strong alumni network and close individual and corporate relationships. The Merage School combines the academic strengths and best traditions of the University of California with the cutting-edge, entrepreneurial spirit of Orange County in the heart of America's Tech Coast.
In 2008, US News & World Report ranked the Merage School #44 in the US, while the Financial Times placed the School at #38 nationally, and #68 internationally. BusinessWeek placed the School within its Top 50 national listing and specifically ranks faculty research and publications at #20. During the past decade, the School has earned Top 10 rankings both nationally and internationally for its executive MBA program, faculty, curriculum components such as IT and marketing, recruitment services and overall value by such publications as: Financial Times, Wall Street Journal, BusinessWeek and US News & World Report.
About The Center For Health Care Management & Policy:
The Center for Health Care Management & Policy serves as an interdisciplinary research institute that enables health care scholars, students, business leaders, policy experts, and professionals to share critical knowledge, research, trends, information and education. The Center is under the direction of Paul J. Feldstein PhD, Professor & Robert Gumbiner Chair in Health Care Management.
SOURCE:
Paul Merage School of Business SB 431
Univ of California
http://merage.uci.edu/ResearchAndCenters/HealthCare/Content/Health-Care-Speaker-Series/159
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09-11-2009 : Drug Information Association (DIA) Names New Worldwide Executive Director
DRUG INFORMATION ASSOCIATION (DIA) NAMES NEW WORLDWIDE EXECUTIVE DIRECTOR
http://www.diahome.org
Horsham PA USA -- Medical Industry E-Mail News™ -- Sept 11 2009 -- The Drug Information Association(DIA) has announced the hiring of Paul Pomerantz, MBA, CAE, as its new Worldwide Executive Director. Paul will transition from his current position as Executive VP of the American Society of Plastic Surgeons (ASPS) to DIA Worldwide Executive Director effective Dec 01 2009. Pomerantz replaces William Brassington, MBA, who has served as Acting Executive Director since July 2008. Brassington will resume his role as Worldwide Director of Finance at DIA.
Pomerantz will direct DIA’s global operations and strategic expansion, and lead the implementation of the Board of Director’s long-term plan for sustainability and growth. He is eager to work with DIA’s board, management team, and staff to take DIA to the next level of excellence.
“This is a changing time for the biopharmaceutical and healthcare community. I’m excited to work with DIA members and constituents to strengthen and expand educational programs and services and advance its global presence and mission. With the growing attention to quality, access and cost of safe medications, DIA can increasingly play a significant role in improving healthcare worldwide,” explains Pomerantz.
Pomerantz brings to DIA more than 25 years of healthcare experience with specialized expertise in medical society management and hospital administration.
“Paul comes to DIA with a proven track record of successfully leading global member-driven associations, developing quality education programs, building coalitions and alliances, and opening doors to new relationships,” says DIA Board of Directors President Dr. Jeffrey Sherman. “Reinforcing our strong relationships with global regulatory agencies, industry and academic professionals, and patient groups is vital to our mission of optimizing global drug development.”
As Executive VP at ASPS, an association of 7,000 reconstructive and cosmetic plastic surgeons, Pomerantz was responsible for the association’s health policy and advocacy initiatives, education and research programs, membership services, communications, and the finance, administration, human resources and information technology departments.
In addition, he recently served (2008-09) as Chair of the Board of ASAE’s Center for Association Leadership. From 1997-2002 Pomerantz was Executive Director for the Society of Interventional Radiology (SIR), an international society representing specialty of radiology that uses image guidance to perform minimally invasive surgical procedures. Prior to SIR, Pomerantz served as Executive Director for the Clinical Laboratory Management Association, Asst VP for the Medical College of Pennsylvania, Executive Director for Maxicare Philadelphia, and Deputy Director for the U.S. Public Health Service.
DIA’s search committee worked with executive search firm Korn/Ferry International to find the most qualified candidate to lead DIA into the 21st century. “The requirements for the position of DIA Worldwide Executive Director have evolved and are particularly challenging,” says Marie A. Dray, DIA immediate-Past President and chair of the search committee. “The position requires experience as an association leader, understanding of the challenges of membership-building, skill in training and educational program development, not to mention state-of-the-art knowledge of global healthcare changes. That really is a tall order, but one we’re confident we have filled with the hiring of Paul Pomerantz.”
About the Drug Information Association (DIA)
As a nonprofit member-driven association, DIA serves more than 30,000 professionals involved in the biopharmaceutical industry, academia, research organizations and governmental bodies worldwide. Through its domestic and international meetings, training courses, workshops and webinars, DIA provides a neutral global forum for the exchange of information critical to the advancement of drug development and medical product lifecycle management. DIA is led by its volunteer Board of Directors and executive management team, has headquarters in Horsham PA USA, and offices in Basel Switzerland, Tokyo Japan, Mumbai India, and Beijing China. For more information, visit http://www.diahome.org or call 215-442-6100.
SOURCE:
Drug Information Association
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09-10-2009 : Biosupply Management Alliance Hosting 2-Day Conference For Marketing & Supply Chain Professionals; South San Francisco; Early Bird Special Ends Sept 30
BIOSUPPLY MANAGEMENT ALLIANCE TO HOST 2ND ANNUAL CONFERENCE FOR MARKETING, RISK MANAGEMENT, IT & SUPPLY CHAIN PROFESSIONALS
-- Early Bird Special Ends Sept 30 -- $395 For 2-Day Conference (Save $500)
-- Rx For a Lean & Healthy Biotech Supply Chain
-- Meeting Challenges of Stakeholders: R&D, Risk Management, Human Resource, Finance, Sales, Marketing & Supply Chain Professionals
-- Oct 19-20 2009 -- South San Francisco Conference Center
http://www.biosupplyalliance.org/events.html
Calabasas CA USA -- Medical Industry E-Mail News™ -- Sept 10 2009 -- The Biosupply Management Alliance (BMA) announced details today of its 2nd Annual Conference that focuses on profitability and growth, Rx For A Lean & Healthy Biotech Supply Chain.
The two-day conference features several dozen leading medical industry executives, and is set for Oct 19-20 2009, at the South San Francisco Conference Center, in the popular northern California Bay Area. The Biosupply Management Alliance (BMA) event provides a forum for collaboration, learning and best practice sharing of practitioners, executives and thought leaders in these uniquely demanding industry sectors.
The popular conference will include tracks for risk management, talent management, supplier management, and systems management. Industry leaders and eminent members of the academia will address the challenges and solutions through collaboration and cooperation between suppliers, manufacturers and customers.
Early Bird Special Ends Sept 30:
Only $395 for the 2-day conference (save $500).
http://www.biosupplyalliance.org/events.html
To receive the early-bird discount, registration needs to be made by phone or email:
818-224-1552
dotti@biosupplyalliance.org
When & Where:
Oct 19-20 2009
South San Francisco Conference Center
South San Francisco CA USA
http://www.ssfconf.com
Background:
The biotech industry has thrived as a new drug incubator for big pharma companies, which have poured money into acquisitions and partnerships to build up their biotech product line. An authoritative analysis will take stock of the economic performance and outlook of the sector in terms of the therapeutic areas, companies, products, technologies, investments, consolidations, competitive environment and governmental regulations.
A comprehensive analysis will be presented of how the industry structure is changing and how genetics, biotechs and generics are increasing clock speed of the pharmaceutical industry. R&D for manufacturability and supply chain effectiveness will also be assessed.
In the emerging sphere of biosimilars, where the regulatory pathways are at the political cross roads, how to successfully bring biosimilar products to market? What can we learn from the European experience?
Who Should Attend This Supply Chain, IT, HR & Risk Management Event:
Executives and professionals in R&D, risk management, upper management, human resource, finance, sales, marketing and supply chain professionals. In particular, C-Level executives of biopharm manufacturers, suppliers, distributors and wholesalers, hospitals, healthcare providers, retail pharmacies, TPLs, purchasing groups, technology solution providers, management consultants, academia and the government.
Presentations & Topics:
A Global Virtual Biotech Network: Accessing The Best Of Breed
Building Blocks of a World-Class Distributor
Cold Chain: Tracking, Temperature-Controlled Transportation Technology
Collaboration: Rx for the Value Chain (AMR Research)
Developing Flexible Mfg Capabilities
Launch & Commercial Mgmt: Overcoming Achilles' Heel
Managing The Enterprise in Turbulent Times
Profiting From Lean Six Sigma in Biotech: Experiences of The Best
Regulatory Influences in Biogenerics: The Next Horizon
Risk Mgmt In The End-To-End Supply Chain
Rx 360: Global QA for Suppliers (Industry Initiative)
Supply Chain Talent Development: The Supply Chain Prerogative
Transforming Industrialization: The Need for a New Product Development Paradigm
Visibility in The Supply Chain: Achieving The Holy Grail
Confirmed Speakers:
Adam Zak; Founder & Principal, Adam Zak Executive Search
Alison Moore; VP, Corporate Mfg, Amgen
Andrew Ramelmeier; VP, Mfg & Process Development, BioMarin Pharmaceutical
Chris Sam; Executive Dir, Risk Mgmt, Amgen
Dave Malenfant; VP, Global Supply Chain, Alcon Laboratories
Devendra Mishra; Adjunct Professor, Graziadio School of Business & Mgmt
Douglas B. Farry MD; McKenna, Long & Aldridge
Ed Church; Executive Dir, Intl Safe Transit Association
Edgar Sur; Head of Operational Excellence, Bayer Healthcare
Frank Hathaway; Supply Chain Excellence, Bayer Healthcare
Gary Hutchinson; Dir, Global Transportation, Amgen
Gary Lynch MD CISSP; Managing Dir/Global Practice Leader Supply Chain Risk Mgmt Practice, Marsh
Gillian R. Woollett; Chief Scientist, Engel & Novitt
James Cox; CEO, Temp Trip
James R. Kellso; Sr Supply Chain Master, Intel Corp
John Figueroa; President, McKesson U.S. Pharmaceutical
Krish Ghosh; VP, Global Resource Mgmt, Covance
Laura Langone; Former SVP, Client Executive, Marsh
Laurel Junk; VP Procurement & Supply Chain, Kaiser Permanente
Mark Buck; Global Supply Chain & Procurement Leader, Bio-Rad Laboratories
Martin Van Trieste; VP, Quality, Amgen
Matt Humphreys; Sr Mgr Consultant, Deloitte Consulting, LLC
Michael Mitchell; Dir, Global Supply Chain, SAFC Biosciences
Mohan Cavale; Principal, NexInfo
Mohinder Sikka; CEO, Sensitel
Nabil Rageh PhD; Professor, Operations Mgmt, Golden Gate University
Phil Kaminsky PhD; Assoc Professor, University of California, Berkeley
Rita Mulcahy PMP; President, RMC Project Mgmt
Robert Wheeler; Genentech
Rodney Derifield; Founder/CEO, EnviroCooler
Ron Bone; Exec VP, Distribution Support, McKesson Pharmaceuticals
Ronald Bone; Sr VP, Distribution Support McKesson US Pharmeceutical
Shankar Suryanarayanan; Co-Program Chairman, Biosupply Management Alliance
Thomas Privette; VP, Strategic Partnering, Covance
Tim Salaver; CEO, Cornerstone Consulting
Timothy Moore; Sr VP, Global Supply Chain, Genentech
Wayne McDonald; Research Dir, Health & Life Sciences, AMR Research
William C Oakley; Sr Dir, Supply Chain Mgmt, SiClone
Sponsorship & Hotel Info:
Call for details.
Registration & Program Info:
Only $395 for 2-day conference (save $500), if you register by Sept 30 2009.
About the Biosupply Management Alliance:
The Biosupply Management Alliance was born of the need to create a worldwide community of operations and supply chain management leaders and professionals in the biotech, biopharm and biomed device industries. Based in the San Francisco Bay Area, home to more than 600 bio firms, the Alliance provides a forum for collaboration, learning and best practice sharing of practitioners, executives and thought leaders in these uniquely demanding industry sectors.
Founders Tim Salaver and Devendra Mishra have forged relationships with key industry leaders and defined initiatives with a vision to create process, people, and policy improvements in this vital sector. These industry partnerships include APICS, Association for Operations Management, Council of Supply Chain Management Professionals, and Institute of Supply Management.
SOURCE:
Biosupply Management Alliance
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09-09-2009 : UC Irvine Center for Health Care Management & Policy Conference Set For Oct 01 2009
UC IRVINE THE MERAGE SCHOOL'S CENTER FOR HEALTH CARE MANAGEMENT & POLICY CONFERENCE ANNOUNCED
-- Comparative Effectiveness: Lessons From Abroad
-- Presented by The Paul Merage School of Business, UC Irvine
-- Expert speakers from Britain, Canada, Germany & US
-- Sept 18 2009 -- Early bird registration deadline
-- Oct 01 2009 -- Beckman Center, Irvine CA USA (adjacent to UC Irvine campus)
http://merage.uci.edu/ResearchAndCenters/HealthCare/Content/Health-Care-Speaker-Series/159
Irvine CA USA -- Medical Industry E-Mail News™ -- Sept 09 2009 --The UC Irvine Center For Health Care Management & Policy at the Paul Merage School of Business announced details today of its upcoming 1-day conference, Comparative Effectiveness: Lessons From Abroad, set for Oct 01 2009.
The conference, part of a regular series, attracts senior management from health care organizations, the public sector, academics, and physician and nurse executives. Attendees have an opportunity to network and meet the speakers at a post-event reception.
Speakers from Britain, Canada, Germany and the US will share insights on their experience, and health care leaders from the US will assess the implications of a similar process in this country.
Focus:
This conference provides a unique venue for dialogue among private and public sector leaders on key issues facing the nation on health care reform. It will help to determine what the US can learn from other countries in using comparative effectiveness (CE) analysis to improve health care quality and efficiency.
Some observes have expressed concern that federal funding for CE research in the US may evolve from providing information to developing a centralized national coverage decision-making process. Can knowledge of the foreign experience with CE enable the US to develop a uniquely American solution that harvests the benefits of better information while preserving independent decision-making?
When & Where:
Date: Thurs Oct 01 2009
Conference: 8:30 am-4:30 pm
Reception: 4:30 pm-5:30 pm
Site:
Arnold & Mabel Beckman Center, Irvine
(adjacent to UC Irvine campus)
National Academies of Sciences & Engineering
100 Academy Dr
Irvine CA 92697
949-721-2200 Beckman Center phone
Driving Directions:
http://merage.uci.edu/go/directions
Register Today:
http://merage.uci.edu/ResearchAndCenters/HealthCare/Content/Health-Care-Speaker-Series/159
Space is limited (all available seating sells out each year)
$395 per person general public through Sept 18 2009
$350 per person UCI Faculty, Staff & Alumni
$450 per person after Sept 18 2009 for all registrations
About the Health Care Speaker Series:
The Distinguished Speaker Program offers an annual series of lectures featuring prominent policy-makers, scholars, journalists, and other opinion leaders who address some of the most pressing issues in healthcare today.
This lecture series was launched in 2001 with Paul Ellwood MD -- the "father of HMOs" and instrumental in forming federal health policy and reforming private sector systems -- asking a provocative question: "Does managed care need to be replaced?" In subsequent years, industry leaders such as John Wennberg MD, director of the Center for the Evaluative Clinical Sciences at the Dartmouth Medical School, John Calfee PhD, resident scholar of the American Enterprise Institute, and Robert Moffit PhD, director of Domestic Policy Studies for the Heritage Foundation joined the list of prominent speakers at this coveted event.
Who Should Attend:
Physicians and nurses in administrative positions, physicians in private, group or clinical practice
Presidents, CEOs, Trustees and senior management in provider and insurer organizations
Senior executives in pharmaceutical, medical device, biotech and other health care organizations who define strategy and policy
Employers who deal with the problem of ever-increasing health care costs while attempting to increase employee choice
Government officials who define and implement health policy
Conference Sponsors:
Kaiser Permanente
California HealthCare Foundation
Event Speakers:
Donald E. Bobo, Jr; Corporate VP, Health Valve Therapy, Edwards Lifesciences
Stirling Bryan MS PhD; Professor of Health Economics, University of British Columbia, Canada
Andrew Dillon; CEO, National Institute for Health & Clinical Excellence, Great Britain
Paul J. Feldstein PhD; Professor & Gumbiner Chair in Health Care Management, Paul Merage School of Business, University of California, Irvine
Marjorie Ginsburg MPH; Executive Director, Center for Health Care Decisions
Peter V. Lee JD; Executive Director, National Health Policy, Pacific Business Group on Health
Murray N. Ross PhD; VP, Kaiser Foundation Health Plan, Director, Kaiser Permanente Institute for Health Policy
Steven D. Pearson MD MSc FRCP; President, Institute for Clinical & Economic Review, Massachusetts General Hospital
Andrew J. Policano PhD; Dean, Paul Merage School of Business, University of California, Irvine
Jill Sanders PhD; President & CEO, Canadian Agency for Drugs & Technologies in Health, Canada
Peter Sawicki MD; Dir of Institute for Quality & Efficiency in Health Care, Germany
Sean Tunis MD MSc; Founder & Director, Center for Medical Technology Policy
Jill Yegian PhD; Dir of Health Insurance, California HealthCare Foundation
Topics Include:
US - Comparative Effectiveness & Health Policy -- This session will present an understanding of current policy and concerns, reform issues, quality and costs. Why is Comparative Effectiveness (CE) on the policy agenda? What is the difference between clinical CE and CE for health benefit coverage? Also discussed will be an understanding of CE analysis -- its usefulness and limitations.
How is Comparative Effectiveness Used Abroad -- Speakers from Britain, Germany and Canada will describe the use of CE in patient treatment decision-making.
Implications of Comparative Effectiveness for the Pharmaceutical, Provider, Payor Sectors & Patients -- Executives from these organizations will discuss the impact of developing a national capacity for Comparative Effectiveness research in the US Will it inevitably lead to payment and coverage decisions?
Advantages & Limitations of a Centralized National Capacity -- Speakers from Britain, Canada and Germany will discuss the issues with executives from pharmaceutical, provider, payor and patient organizations. What can be adopted from other countries and what will not work here? How do other countries handle the issues of innovation and R&D? How do other countries handle stakeholder perspectives and opposition?
Registration & Fees:
Only paid registrations will have a confirmed seat. Reservations by mail must be postmarked no later than Fri Sept 18 2009. After this date, only faxed registrations with credit card payment will be accepted. Registration fee is per person, includes all sessions, breakfast, lunch, coffee breaks, buffet reception and conference materials.
About The Paul Merage School Of Business:
The Paul Merage School of Business at UC Irvine offers four dynamic MBA programs -- plus PhD & undergraduate business degrees -- that deliver its thematic approach to business education: sustained growth through strategic innovation. We graduate leaders with the exceptional ability to help grow their organizations through strategic innovation -- supported by analytical decision-making, information technology and collaborative execution, and enhanced by a highly-personalized learning environment. In-class and onsite experiences with real-world business issues give our students the edge needed to help companies compete in today's global economy.
http://www.merage.uci.edu
While the Merage School is relatively young, it has quickly grown to consistently rank among the top 10% of all AACSB-accredited programs through exceptional student recruitment, world-class faculty, a strong alumni network and close individual and corporate relationships. The Merage School combines the academic strengths and best traditions of the University of California with the cutting-edge, entrepreneurial spirit of Orange County in the heart of America's Tech Coast.
In 2008, US News & World Report ranked the Merage School #44 in the US, while the Financial Times placed the School at #38 nationally, and #68 internationally. BusinessWeek placed the School within its Top 50 national listing and specifically ranks faculty research and publications at #20. During the past decade, the School has earned Top 10 rankings both nationally and internationally for its executive MBA program, faculty, curriculum components such as IT and marketing, recruitment services and overall value by such publications as the Financial Times, The Wall Street Journal, BusinessWeek and US News & World Report.
About The Center For Health Care Management & Policy:
The Center for Health Care Management & Policy serves as an interdisciplinary research institute that enables health care scholars, students, business leaders, policy experts, and professionals to share critical knowledge, research, trends, information and education. The Center is under the direction of Paul J. Feldstein PhD, Professor & Robert Gumbiner Chair in Health Care Management.
SOURCE:
Paul Merage School of Business, SB 431
University of California
http://merage.uci.edu/ResearchAndCenters/HealthCare/Content/Health-Care-Speaker-Series/159
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09-08-2009 : FDAnews Announces FDA Inspections Summit; Featuring 10 FDA Officials; Oct 21-23 2009; Washington DC
FOURTH ANNUAL FDA INSPECTIONS SUMMIT PRESENTED BY FDANEWS
-- Oct 21-23 2009 -- Marriott Bethesda North Hotel & Conference Center, Bethesda MD
-- Sept 18 2009 -- Early-Bird discount deadline
http://www.FDAInspectionsSummit.com
Falls Church VA USA -- Medical Industry E-Mail News™ -- Sept 08 2009 -- FDAnews announced details today of its Fourth Annual FDA Inspections Summit, set for Oct 21-23 at the Marriott Bethesda North Hotel & Conference Center, Bethesda MD.
Background:
Beginning Sept. 15 the FDA will expect you to file responses to Form 483s within 15 business days. No ifs, ands or buts. If you don't -- a warning letter could be issued -- fast.
The new rule is one of six key enforcement steps announced by FDA Commissioner Margaret Hamburg. Others include introducing the "closeout" letter -- which she hopes will become a top industry priority -- speeding up the issuance of warning letters, and in certain cases cracking down without prior issuance of a warning letter.
The latest rules are in line with the agency's get-tough enforcement policy, a stark contrast to the Bush years. Drug import field enforcement examinations and international cGMP inspections are to more than double in fiscal 2010, and many other areas also are to fall under increased scrutiny. The agency is adding hundreds of regulatory staffers and investigators and opening new offices in China, India, Latin America and elsewhere.
In response, FDAnews has invited top FDA regulators to discuss their plans with drug and device executives at an October summit in Washington.
FDA speakers include:
Joshua Sharfstein; Principal Deputy Commissioner, FDA
Deborah Autor; Director, Office of Compliance, CDER, FDA
Larry Spears; Deputy Director for Regulatory Affairs, CDRH, FDA
Kimberly Trautman; Medical Device Quality Systems/GMP Expert, CDRH, FDA
Leslie Ball; Director, Div of Scientific Investigations, Office of Compliance, CDER, FDA
Donna Headlee; Consumer Safety Officer, CDRH, FDA
Evelyn Bonnin; Baltimore District Director, ORA, FDA
Lori Lawless; Acting SCSO, Medical Device Specialist, ORA, FDA, Baltimore District
Christine Drabick; Bioresearch Monitoring Branch, CBER, FDA
Stephanie Shapley; Bioresearch Monitoring Branch, ORA, FDA, Baltimore District
Twelve more speakers round out the roster, including executives of leading drug- and device makers, plus industry consultants and lawyers.
A full speaker roster is at: http://www.FDAInspectionsSummit.com
Highlighted speakers include:
Michael Beatrice, VP, Corporate Regulatory & Quality, Abbott Laboratories
Tracy Panella, Compliance Excellence Program Director, Global Quality & Compliance, Wyeth Pharmaceuticals
Patricia Shrader, Sr VP, Corporate Regulatory & External Affairs, Becton Dickinson
Steven Niedelman, Sr Consultant, Crowell & Moring
Barbara Immel, Conference Chair & President, Immel Resources LLC
Full program details & information are at: http://www.FDAInspectionsSummit.com or by calling 888-838-5578.
CONFERENCE REGISTRATION INFORMATION
BONUS PRE-CONFERENCE AFTERNOON WORKSHOP
Register now for the pre-conference workshop:
"Applying Risk Management in Preparing for a Regulatory Inspection"
-- Presenter: James Vesper, President, LearningPlus
This special Wednesday afternoon Pre-Conference Workshop will instruct participants in a practical, risk-management-oriented model to prepare for a visit from FDA investigators, with tools and rationales they can put to use right away.
Who Should Attend the Summit:
Executive Management
Regulatory Affairs
Quality Assurance/Quality Control
Legal & Compliance Officers
Clinical Research Directors
Consultants/Service Providers
Location & Hotel Accommodations:
To reserve your room, call the hotel at the number below. Be sure to tell the hotel that you're with the FDAnews Supplier Quality Management Congress conference to qualify for the reduced rate. Only reservations made by the reservation cut-off date are offered the special rate, and space is limited. The hotel may run out of rooms before the reservation cutoff date. The discounted rate is also available one night before and after the event based on availability. The hotel may require the first night's room deposit with tax. Room cancellations within 24 hours of the date of arrival or "no-shows" will be charged for the first night's room rate plus tax.
Bethesda North Marriott Hotel & Conference Center
5701 Marinelli Rd
Bethesda MD 20852
800-859-8003 phone
301-822-9200 phone
http://www.bethesdanorthmarriott.com
Special Conference Room Rate:
$199 single or double (plus 12% tax)
Hotel reservation cutoff date: Sept 30 2009
Team Discounts:
Significant discounts are available for teams of three or more from the same company. You must register at the same time and provide a single payment to take advantage of this discount. Call 703-538-7600 for details.
Tuition Early Bird Rates:
Conference & Workshop Early Bird Rate Through Sept 18 - $1,797
Conference Only Early Bird Rate Through Sept 18 - $1,527
Workshop Only Early Bird Rate Through Sept 18 - $537
Tuition Regular Rates:
Conference & Workshop for Sept 19-Oct 23 - $1,997
Conference Only for Sept 19-Oct 23 - $1,697
Workshop Only for Sept 19-Oct 23 - $597
Register Today:
1. Enroll online at: http://www.FDAInspectionsSummit.com
2. Call 703-538-7600 or 888-838-5578
Use your American Express, Visa or MasterCard
3. Mail your check to:
FDAnews
300 N Washington St Ste 200
Falls Church VA USA 22046-3431
ABOUT FDANEWS
FDAnews publishes domestic and international regulatory, legislative and business news and information for executives in industries regulated by the US FDA. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books, management reports and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations to get their products to market faster and boost profits. FDAnews brings you the knowledge you need, when you need it.
CONFERENCE CHAIR
Barbara K. Immel is President of Immel Resources LLC, a management consulting firm specializing in quality systems, regulatory compliance, and training. For more than 27 years, Ms. Immel has been one of the most listened-to voices in FDA-regulated industry. She has taught at the Universities of California-Berkeley, Wisconsin, Georgia and Stanford; authored more than 50 articles in industry journals; and wrote the quality assurance chapter in Dekker's Encyclopedia of Pharmaceutical Technology. She is a former compliance columnist for BioPharm Magazine and is currently editor of the Immel Report™ newsletter.
SOURCE:
FDAnews
300 N Washington St Ste 200
Falls Church VA USA 22046-3431
http://www.FDAInspectionsSummit.com
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09-03-2009 : FDAnews Announces REMS Summit Featuring Dr. Janet Woodcock, Jane Axelrad & Sir Alasdair Breckenridge; Oct 1-2 2009; Washington DC
SECOND ANNUAL RISK MANAGEMENT & DRUG SAFETY SUMMIT
-- Presented by FDAnews in Conjunction with United BioSource Corp & Center for Medicine in the Public Interest
-- Early-Bird Rate in Effect Though September 11 -- Register Now for Best Rate
-- Oct 01-02 2009 -- National Press Club, Washington DC
http://www.DrugSafetySummit09.com
Falls Church VA USA -- Medical Industry E-Mail News™ -- Sept 03 2009 -- FDAnews, in conjunction with United BioSource Corp and the Center for Medicine in the Public Interest, announced today they are hosting the Second Annual Risk Management & Drug Safety Summit on Oct 01-02 2009 at the National Press Club, Washington DC.
BACKGROUND
Clinical research, drug development, regulatory approval and pharmacovigilance segments of the drug and biologic industries are at a crucial crossroads. New risk management programs from the FDA, known as REMS, promise a competitive advantage to companies that incorporate REMS early in the NDA approval cycle, then stay close to the FDA through post-market monitoring and beyond. But compliance challenges are daunting.
How do you evaluate the effectiveness of your REMS? What is the impact of developing a REMS on your clinical trials, organizational structure, reporting and governance? What lessons have REMS pioneers learned that might benefit you? These are but a few of the questions swirling around this new get-tough approach to risk management and drug safety regulation.
Come to Washington DC, Oct 1-2, and discover how your company can cope with and adjust to REMS. The SECOND ANNUAL RISK MANAGEMENT & DRUG SAFETY SUMMIT is set for Oct 1-2, at the National Press Club, Washington DC.
FDA SPEAKERS TO INCLUDE:
Janet Woodcock MD; Director, CDER, FDA
Jane Axelrad; Assoc Dir for Policy, CDER, FDA
In addition, the top UK drug regulator has been invited as a special presenter. Hon. Sir Alasdair Breckenridge is Chair, Medicines & Healthcare Products Regulatory Agency, UK.
Eight more speakers representing leading drug makers as well as industry consultants and attorneys, round out the program:
Carmen Bozic MD; VP Drug Safety & Risk Mgmt, Biogen Idec
Juergen Schmider MD PhD; VP Global Pharmacovigilance & Epidemiology, Cephalon
Philippe van der Auwera MD PhD; Global Head, Safety Risk Mgmt, F. Hoffmann-La Roche AG
Gerald Faich MD MPH FISPE; Sr VP Safety, Epidemiology, Registries & Risk Mgmt, United BioSource Corp
Meredith Manning Esq; Partner, Hogan & Hartson
Florence Houn MD; VP Regulatory Policy & Strategy, Celgene
Mark Ammann PharmD; VP Regulatory Affairs, United BioSource Corp
Brian Harvey MD PhD; VP Regulatory Policy, Sanofi-Aventis US
FURTHER PROGRAM DETAILS:
Full program details and registration information is available at:
http://www.DrugSafetySummit09.com or by calling 888-838-5578.
CONFERENCE REGISTRATION INFORMATION
CONFERENCE CO-CHAIRS:
Annette Stemhagen DrPH FISPE; VP, Epidemiology & Risk Management, United BioSource Corp
Peter Pitts; Co-Founder & President, Center for Medicine in the Public Interest
WHO SHOULD ATTEND:
Executive Management
Regulatory Affairs
Medical Affairs
R&D
Clinical Trial Directors
LOCATION & HOTEL ACCOMMODATIONS:
The National Press Club is at the corner of 14th & F Streets NW, in the heart of downtown Washington DC. Hotel rooms have not been blocked for this event. For a list of 3-to-5-star hotels within walking distance, please visit http://www.DrugSafetySummit09.com or call 888-838-5578.
TEAM DISCOUNTS:
Significant discounts are available for teams of three or more from the same company. You must register at the same time and provide a single payment to take advantage of this discount. Call 703-538-7600 for details.
TUITION:
Early-Bird Rate Through Sept. 11: $1,997
Regular Rate After Sept. 11: $2,297
REGISTER TODAY:
1. Enroll online at http://www.DrugSafetySummit09.com
2. Call 703-538-7600 or 888-838-5578
3. Use your American Express, Visa or MasterCard
4. Mail your check to:
FDAnews
300 N Washington St Ste 200
Falls Church VA USA 22046-3431
ABOUT FDANEWS:
FDAnews publishes domestic and international regulatory, legislative and business news and information for executives in industries regulated by the US Food & Drug Administration.
Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books, management reports and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations to get their products to market faster and boost profits. FDAnews brings you the knowledge you need, when you need it.
SOURCE:
FDAnews
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09-02-2009 : Noblitt & Rueland Announces San Francisco Bay Area Training on Medical Device Compliance Issues; Oct 26-30 2009
5 TRAINING COURSES TO DISCUSS FDA ENFORCEMENT & INTL COMPLIANCE ISSUES IN SAN FRANCISCO BAY AREA
-- Topics that have become top priority for FDA inspectors & reviewers will be covered, along with key international compliance problems
-- Training goal is to help companies avoid regulatory enforcement action & be more efficient in the process
-- Oct 26-30 2009 -- Embassy Suites on the San Francisco Bay, Burlingame CA USA
http://www.fdatraining.com/trains.shtml
Irvine CA USA -- Medical Industry E-Mail News™ -- Sept 02 2009 -- Noblitt & Rueland today announced further details of its regulatory seminar schedule for Oct 2009. All events will be held at the Embassy Suites Hotel on the San Francisco Bay, Burlingame CA USA.
Topics that have become top priority for FDA reviewers and compliance inspectors will be covered, to help protect you and your company from severe regulatory enforcement action.
OCT COURSES: EMBASSY SUITES ON THE SAN FRANCISCO BAY, BURLINGAME CA (attend any 1 or more training programs)
Oct 26; Mon -- FDA Quality System Regulation (QSR/GMP) & FDA Inspections
Oct 27; Tue -- Auditing Quality Systems for FDA & ISO Compliance
Oct 28; Wed -- Design Control, the FDA & ISO
Oct 29; Thu -- Risk Management, ISO 14971 and FDA Requirements
Oct 30; Fri -- Software Verification & Validation Strategies
VENUE:
Embassy Suites on the San Francisco Bay, Burlingame CA USA Convenient to San Francisco Airports, Downtown San Francisco and Silicon Valley
Special course discounts, including multiple attendee discounts, are available.
COURSE DESCRIPTIONS:
http://www.fdatraining.com/trains.shtml
TO DOWNLOAD A SEMINAR BROCHURE:
http://www.fdatraining.com/training_brochures.pdf
TO REGISTER:
http://www.fdatraining.com/registerforms.shtml
FOR REGISTRATION & HOTEL INFO:
http://www.fdatraining.com/reginfos.shtml
CRITICAL ISSUE HIGHLIGHTS: FDA & ISO MEDICAL DEVICE HOT TOPICS:
NEW ADMINISTRATION in the White House and new FDA Commissioner means new direction for the FDA. Recent high profile cases and outside agency government reports indicate that additional QSR enforcement, oversight, more rigorous 510(k) reviews, and additional regulation are not just on the horizon, but are now happening. Below we discuss some of these activities and during our training we will be discussing the potential impact of all of these critical actions to medical device manufacturers.
FDA CHANGES POLICY ON WARNING LETTER REVIEWS. FDA is changing their program on the issuance of warning letters in an effort to facilitate the issuance of warning letters in a timelier manner. Beginning September 15 the adequacy of written responses by an inspected company to FDA 483 observations that are received within 15 days of the FDA 483 being issued will be considered in determining whether a warning letter should be issued. The adequacy of the 15 day response will also be recognized in the warning letter if it is issued. Reponses to FDA 483 observations received after 15 days will be reviewed along with other documents and information received in response to a warning letter when issued.
FDA QUALITY SYSTEM INSPECTION RESULTING IN 510(K) REVIEWS & POSSIBLE WITHDRAWS. A recent FDA quality system inspection of a company in southern California and the resulting Warning Letter comments suggest to the receiving company that it should review several previously cleared 510(k) applications and consider withdrawing the cleared applications if the data is thought to be unreliable or unverifiable. Companies submitting 510(k)s need to be aware that data supporting the 510(k) may be investigated during your quality system inspection.
DESIGN CONTROL AND SOFTWARE CONTINUE TO BE COMPLIANCE ISSUES BEING CITED IN FDA WARNING LETTERS. Companies have received warning letters for Design Control related issues including issues such as inadequate Software Verification & Validation for device, production, and quality system software; and Risk Management activities. Proper Risk Management activities and documentation have helped companies comply and demonstrate the adequacy of their Design Control activities.
510(k) PROGRAM MODIFICATIONS POSSIBLE. FDA's role or lack of oversight on manufacturer's decisions when deciding not to submit information to FDA regarding device modifications is being questioned by Senator Grassley of Iowa in a letter sent to the Acting FDA Commissioner and the overall 510(k) process is being reviewed. Manufacturers may be greatly impacted if the agency changes their current policy & guidance on 510(k)s and when to submit a new 510(k) for changes to a device.
LAST DAY TO DISTRIBUTE PRODUCT UNDER THE OLD VERSION OF THE MDD IS MARCH 21 2010. After that, all distributed product must comply with the 2007 revision of the MDD. The same date applies to the revision of the AIMDD. You have just approximately 7 months left to update all technical files and design dossiers. Although the installed base is not affected, there is no grandfathering for products distributed after March 21, 2010 (regardless of how long the version has been distributed previously in Europe). Please call or e-mail if you have questions or need assistance in complying and meeting the deadline.
ENFORCEMENT ACTIONS ARE VERY COSTLY. Judgments and enforcement actions by the FDA should motivate companies and their management to ensure that their companies are compliant with the Quality System (QS/GMP) regulations. Enforcement actions resulting from GMP/QS regulation violations have been very serious and have included consent decrees, $100+ mln & $500+ mln fines, corporate warning letters, injunctions to stop manufacturing due to QSR and Design Control issues, and international firms receiving import detention, etc. A recent US District court complaint against a US medical device manufacturer specifically cites inadequate quality system training of both employees and management in support of a seizure order.
SEVERITY OF ENFORCEMENT PENALTIES HAS INCREASED. Repeat offenders and management should beware of this worsening potential.
REQUIREMENT FOR INTERNAL AUDITING WHEN PERFORMED EFFECTIVELY HAS SAVED MANY COMPANIES BOTH ENFORCEMENT HEADACHES & PENALTIES. Companies have avoided negative competitive and investor relations by finding and correcting deficiencies prior to FDA inspections. These corrections have prevented FDA enforcement actions and Warning Letters from being issued, published on the Internet, and being available to competitors for distribution to customers. In addition, many companies have found that investors become nervous when FDA enforcement actions occur. Obviously, many times the firms experience a negative impact to their stock price or funding.
DOWNLOAD A PROGRAM BROCHURE:
http://www.fdatraining.com/training_brochures.pdf
COURSE-SPECIFIC INFO INCLUDES A BRIEF OUTLINE FOR EACH COURSE:
http://www.fdatraining.com/trains.shtml
REGISTER ONLINE AT:
http://www.fdatraining.com/registerforms.shtml
or by fax at 714-258-3990.
FOR ADDITIONAL HOTEL & REGISTRATION INFO:
http://www.fdatraining.com/reginfos.shtml
Printed brochures and registration are available by phone at 714-258-4646 or 888-892-4664 (in the US & Canada).
SOURCE:
Noblitt & Rueland
http://www.fdatraining.com/trains.shtml
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09-01-2009 : BioWorld Today Releases New Report: Advancing Vaccines: New Science, New Opportunities
BIOWORLD TODAY RELEASES NEW REPORT: ADVANCING VACCINES: NEW SCIENCE, NEW OPPORTUNITIES
-- 100 pages -- Seasonal & swine flus are discussed
-- Covers science behind vaccines, including cancer & HIV
-- Concise details on the pandemic crisis
http://www.bioworld.com/servlet/com.accumedia.web.Dispatcher?next=S09446_8541
Atlanta GA USA -- Medical Industry E-News Service™ -- Sept 01 2009 -- The publishers of BioWorld Today have just released "Advancing Vaccines: New Science, New Opportunities," a report that synthesizes the emerging science behind vaccines, and how biotechnology and pharmaceutical companies are using that science against our deadliest foes: pandemics, cancer and HIV.
An example of topics discussed include:
Cancer vaccines
HIV vaccines
Seasonal and pandemic flus
Sciences behind vaccines
And much more
"The market for vaccines is expanding fast as scientists and drug developers move quickly to turn promise into cures. Vaccines used to be to prevent illness, but now vaccines are being developed to treat people already ill," says Managing Editor Glen Harris. "This report updates the key recent scientific developments relating vaccines, and discusses the problems and successes drug developers have had in the field."
PEOPLE WHO NEED THIS REPORT:
Pharma R&D specialists
Regulatory professionals
Vaccine manufacturers
Infection control professionals
Health professionals
Research scientists
Attorneys serving biotech firms
Immunologists
Risk managers
INFORMATION AVAILABLE ONLINE:
To view the table of contents, samples pages, and to obtain ordering information, please visit:
http://www.bioworld.com/servlet/com.accumedia.web.Dispatcher?next=S09446_8541
HOW TO ORDER THIS REPORT:
The full version of the report is available in print. Orders can be placed online at:
http://www.bioworld.com/servlet/com.accumedia.web.Dispatcher?next=S09446_8541
For priority delivery, please call 404-262-5476 or 800-688-2421.
ABOUT BIOWORLD:
BioWorld, published by AHC Media LLC, is an internationally recognized information provider for executives, analysts and investors following the day-to-day developments in the biotechnology, pharmaceutical and medtech markets. Focusing on scientific business news and information, BioWorld's websites provide access to daily developments in these sectors, as well as 18 years' worth of archived data, trends and company information.
Key products include BioWorld Today -- the newspaper of record for the biotech industry; BioWorld Insight -- a weekly monitor of biotech's financial markets; BioWorld International -- focusing on life science developments in Europe; and Medical Device Daily -- delivering daily business intelligence for the medtech industry.
SOURCE:
BioWorld Today
http://www.bioworld.com
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08-27-2009 : HealthAchieve2009 Conference & Exhibition to feature Newt Gingrich, Dr. Sanjay Gupta, Michael Moore; Nov 16-18 2009, Toronto Canada
HEALTHACHIEVE2009 CONFERENCE & EXHIBITION IN TORONTO
-- One of the largest and most prestigious health care events in North America presents unique, high-profile marketing opportunities
-- Nov 16, 17 & 18 2009 -- Metro Toronto Convention Centre, Toronto, Ontario Canada
-- More than 9,000 delegates from across the health care sector discovering the latest, cutting edge technology, set to transform the future of health care delivery
http://www.healthachieve.com
Toronto Ontario Canada -- Medical Industry E-Mail News Service™ -- Aug 27 2009 -- The perfect forum for both sharing and discovering the latest advancements in health care, HealthAchieve2009 is scheduled to take place on Nov 16, 17 & 18 2009. It presents a unique opportunity to showcase your organization's products, services and technologies with over 9,000 health care professionals and 350 exhibitors at the Metro Toronto Convention Centre.
Many of the delegates who attend HealthAchieve are the hardest to reach professionals in the health care industry: hospital and health care associations CEOs, board chairs, trustees, senior management, financial and information technology decision influencers.
A presence at HealthAchieve means:
Enhanced visibility among targeted groups of health care professionals, including CEOs, financial managers, pharmacists, educators, technologists, infection control specialists, purchasing staff, trustees, nurses, environmental professionals, human resources managers, discharge planners and more.
Cross-promotional opportunities by participating in "subject matter" groupings to attract like-minded customers. E.g., HealthAchieve's "Silicon Alley" will be comprised of companies showcasing the latest cutting-edge technology in health care.
A chance to see what the competition is doing. An event of HealthAchieve's caliber allows you to make important business connections, create customer awareness, do market research, and stay on top of industry trends.
Association with an award-winning event. HealthAchieve is consistently recognized as one of the largest, most prestigious health care conferences of its kind. One of its most recent awards is the Best Trade Show Award from the annual Canadian Event Perspective Magazine Star Awards.
Interacting with the best and brightest minds in today's health care and business sectors.
Book your sponsorship, advertising, and/or exhibit spaces now. Opportunities are selling fast. The exhibit floor is already 75% sold out.
BENEFITS TO PARTICIPATING:
Complimentary Exhibit Floor Passes: Each exhibiting company is entitled to 10 complimentary passes. Invite your clients to visit you on the exhibit floor.
"Getting Results at HealthAchieve2009" Conference: This complimentary educational session hosted by Show Management will help you gain insight into how to best present your organization and position your products/services to meet the needs of the health care industry. It is also an excellent networking opportunity.
Pre-show Delegate Listing: Know who is coming to the show before you get there. Conduct pre-show marketing by taking advantage of the pre-show delegate list that will be sent to exhibitors and sponsors two weeks prior to the event.
Exhibitor Event Posting on HealthAchieve Website: If you're hosting an after-hours event, it can be promoted on the HealthAchieve website.
Complimentary Postcard Invitation to Your Guests: HealthAchieve Show Management, together with Magjak Exhibitor Marketing Services, allows you to effectively connect with your customers and prospects prior to HealthAchieve using targeted, personalized direct marketing tactics that are proven to generate higher awareness over conventional pre-show direct mail marketing. Magjak's marketing team will work with you to create a pre-show marketing plan that will help to drive awareness and traffic to your exhibit space during the show.
Integrated Marketing Options: Increase your visibility through the sponsorship of events and sessions during the event. Engage in an integrated approach to your marketing by utilizing multiple touch points and make the most of your time and investment at HealthAchieve.
Complimentary Registration to All Educational Sessions: Network while learning by attending at no-charge, any educational session (except ticketed events or by invitation) during all three days of HealthAchieve.
Receptions for Networking Opportunities: Multiple receptions will be held to create additional networking opportunities for delegates and exhibitors. Visit the HealthAchieve website to view the complete list.
Exhibitor Private Meeting Rooms: Two meeting rooms will be allocated on the exhibit floor specifically for exhibitors and delegates to conduct private business meetings. Make the most of your time at HealthAchieve and set up meetings with the clients you've been waiting to meet.
Lead Retrieval System: Lead retrieval units which will enable the gathering and storage of detailed information on each attendee visiting your exhibit space will be made available through the HealthAchieve registration company.
Post-Show Delegate Listing: Build on the contacts you made at HealthAchieve by utilizing the post-show delegate list, which will be sent to you after the event to conduct post-show marketing and follow up. Ensure you reach out to all the people who attended the event and make the most of the information you have.
Matchmaking: A list of delegates who have expressed interest in your organization's products or services will be sent to you so that you can conduct post event follow up and ensure they receive information about your company's offerings.
Company Listing On Website: Your company listing will remain posted on the HealthAchieve website for the entire year following the event to ensure that people who want to find you can do so.
Hear what exhibitors are saying about HealthAchieve
See which exhibit spaces are still available
For more information on exhibit space rates & reservation information
For information on sponsorship & advertising
Exhibit, Sponsorship & Advertising Prospectus
KEYNOTE ADDRESSES BY:
Dr. Sanjay Gupta, Chief Medical Correspondent for CNN
Michael Moore, Academy Award Winning Documentarian & Best-Selling Author
Richard Florida, Renowned Economist & Author
Newt Gingrich, Conservative Political Visionary & Thought Leader
View Program Highlights
Online Registration
Full Information
SOURCE:
HealthAchieve2009
200 Front St W Ste 2800
Toronto Ont M5V 3L1 Canada
http://www.healthachieve.com
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08-26-2009 : Innovative Tool From The Robert E. Nolan Company To Help Hospitals Plan In Uncertain Times
INNOVATIVE TOOL FROM THE ROBERT E. NOLAN COMPANY TO HELP HOSPITALS PLAN IN UNCERTAIN ECONOMIC TIMES
-- Tool Assists Hospitals In Exploring The Variables & Impacts Related To Health Care Reform Proposals
-- Download complimentary copy:
http://www.renolan.com/framework:
Dallas TX USA -- Medical Industry E-Mail News Service™ -- Aug 26 2009 -- The Robert E. Nolan Company, a leading managed care consulting firm (http://www.renolan.com), announced today the availability of its new "Hospital Planning Framework."
The Framework is an interactive model that allows hospitals to model key financial and performance variables including: payer mix, reimbursement rates, cost structure, financial results, impact on their staffing levels, and impact on the hospital's local economy. The Nolan Framework is the only freely available model hospitals can use to explore the variables and impacts related to health care reform proposals.
The Framework is of particular importance, given the high degree of uncertainty about hospital finance in light of various proposals for health care reform. The model allows a hospital to simulate differing government proposals and their impact on hospital financials, and allows hospital executives to test potential management actions.
The Framework is available without charge from:
http://www.renolan.com/framework
"The Framework is the right tool at the right time for hospitals facing high anxiety from potential changes from health care reform. Different reform proposals have surprisingly different impacts on hospitals based on size and service mix. We're happy to make The Framework available as a way of introducing hospitals to Nolan's modeling and staff planning services," said Merit Smith, director of Nolan's health care practice.
Nolan is a leading managed care consultancy that specializes in solving service, cost and productivity problems in managed care firms. For more information about The Framework or Nolan, visit http://www.renolan.com or call 800-248-3742.
SOURCE:
Robert E. Nolan Company
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08-25-2009 : CE in Biotech & Pharmaceutical: 11th CASSS Symposium on Practical Applications for Analysis of Proteins, Nucleotides & Small Molecules; Oct 11-15 2009
CE PHARM 2009: CE SYMPOSIUM IN THE BIOTECH & PHARMACEUTICAL INDUSTRIES ANNOUNCED
-- 11th Symposium on the Practical Applications for the Analysis of Proteins, Nucleotides & Small Molecules
-- Oct 11-15 2009 -- Boston Park Plaza, Boston MA USA
http://www.casss.org/displayconvention.cfm?conventionnbr=6003
Emeryville CA USA -- Medical Industry E-Mail News Service™ -- Aug 25 2009 -- The 11th Symposium on the Practical Applications for the Analysis of Proteins, Nucleotides & Small Molecules, Oct 11-15 2009, will provide a forum to discuss recent developments in CE analysis of protein, nucleotide and small molecule pharmaceuticals.
The presentations and workshops will be devoted completely to practical concerns to strengthen the use of CE within the biotech and pharmaceutical industries. Applications will highlight uses of CE in various areas of product development including high throughput screening, formulation studies, process development, product characterization, and validated lot release and stability testing.
The Symposium will feature presentations from leading experts within the industries and the regulatory agencies (FDA, Health Canada, and European Pharmacopeia).
The workshops will allow for open discussions of specific techniques and/or applications including protein analysis, carbohydrate analysis, CE/MS, oligonucleotide and chiral separations, as well as validation of CE assays for product release. Specifically, two workshops will focus on the implementation of assays, including assay troubleshooting, assay transfer and instrument qualification (IQ/OQ/PQ).
SUBMIT YOUR ABSTRACTS NOW:
Poster Deadline has been extended until Aug 31 2009. Click below to submit your abstract:
http://casss.org/displaycommon.cfm?an=1&subarticlenbr=225&convnbr=6003&showmember=5773433
PRELIMINARY LIST OF INVITED SPEAKERS:
This year's symposium will include lectures, posters, workshops and a short course. The preliminary scientific programs will be available by the end of August.
Speakers:
Applications of Capillary Isoelectric Focusing in Development of Recombinant Vaccines; Carrie L. Anderson, Merck
Capillary SDS of Antibodies: What can be resolved?; Tim Blanc, ImClone Systems Inc
Coupling of Single Drop Micorextraction with Capillary Electrophoresis-Mass Spectrometry; Doo Soo Chung, Seoul National University
Optimization of a Routine CE-Based Carbohydrate Assay to Minimize Sample Preparation Artifacts; Lynne Gennaro, Genentech
Update on Heparin Contamination: Assessment of Optimized Capillary Electrophoresis, Proton NMR & Ion-Exchange HPLC Methodologies; Michel Girard, Health Canada
Sample Preparation Issues in Glycan Analysis by Capillary Gel Electrophoresis
Andras Guttman, Barnett Institute, Northeastern University
Analysis of Plasmid Topoisomers & Restriction Map with Capillary Gel Electrophoresis-Laser Induced Fluoresence; Yan He, Pfizer Global Biologics
CE in Development of Follow-on Biologics; Sarah Kennett, FDA
CGE Method Development & Optimization for Therapeutic Oligonucleotides; Hanlin Li, Pfizer Inc
Analysis of Peptide-Protein Conjugates Using Imaged Capillary Isoelectric Focusing; Colin Medley, Pfizer Global Research
Indirect Identification of CIEF Charge Isoform Peaks Using an Offline Fractionator; David Michels, Genentech
Evaluation of Multi-Array Capillary Electrophoresis for High Throughput Analysis of Small Molecules; Beverly Nickerson, Pfizer Inc
Evaluation of CIEF as a Toolbox Method for Charge Heterogeneity: Reducing Development Time & Increasing Data Consistency; Kevin Overstreet, Eli Lilly & Co
CE for Complex Analyses in Clinical Biochemistry; David Perrett, William Harvey Research Institute
Monitoring Intracellular Activity of Arylsulfatase B on its Natural Substrates in a Functional Bioassay Using LIF-CZE; Erno Pungor, BioMarin
Towards High Throughput Characterization of Glycosylation-Patterns Using a Capillary-DNA-Sequencer; Erdmann Rapp, Max-Planck-Institute for Dynamics of Complex Technical Systems
Validation of a CE Method for Determination of OSCS Contamination in Low Molecular Weight Heparin, Enoxaparin; Raghvendra Sahai, EuTech Scientific Services Inc
A Novel High-Sensitivity & High-Throughput CE-IEF Nanoimmunoassay to Assess Charge Heterogeneity of Protiens; Oscar Salas-Solano, Genentech
Use of Capillary Electrophoresis for the Quality Control of Pharmaceutical Formulations Produced in Hospital Pharmacy; Sandrine Fleury Souverian, University of Geneva
USP Heparin Monographs & Reference Standards - Stage 2 Revision Implementation; Anita Szajek, US Pharmacopeial Convention
CE-MS Applied to Forensic Toxicology Analysis; Franco Tagliaro, University of Verona
Capillary Electrophoresis: Technology to Find the Genes (if any) That Carry Risk for Common Diseases; William Thilly, MIT
New Insights in Intact Protein Analysis by CE-TOF-MS; Jean-Luc Veuthey, University of Geneva
Metabolome Analysis of a Bottom-Fermenting Yeast Using CE-MS; Satoshi Yoshida, Kirirn Research Labs
SCHEDULE OF SHORT COURSES:
This year the short courses will be held on Sunday Oct 11 and Thursday Oct 15 starting at 9 AM. The short courses will give attendees the opportunity to network among colleagues in a small classroom setting, which will allow for in-depth discussions.
Sunday Oct 11:
-- Applications of CE to the Analysis of Protein Therapeutics
Oscar Salas-Solano, Genentech, Inc., South San Francisco CA USA
Chantal Felten, Cardiome Pharma Corp, Vancouver BC Canada
Thursday Oct 15:
-- Method Optimization & Troubleshooting in Capillary Electrophoresis
Kevin Altria, GlaxoSmithKline R & D, Essex UK
ADDITIONAL HIGHLIGHTS:
During the conference the program is proud to present speakers from around the globe. Don't miss diversified sessions throughout the week including but not limited to impurity determination in heparin at the regulatory session with speakers from Canada, Europe and the FDA.
Highlights for the year also include but are not limited to:
Nucleotides Analysis: Capillary Electrophoresis: Technology to find the genes (if any) that carry risk for common diseases; Professor William Thilly, MIT, Cambridge MA USA
Food Analysis: Metabolome analysis of a bottom-fermenting yeast using CE-MS; Satoshi Yoshida, Kirin Research Labs, Yokohama-shi Kanagawa Japan
Forensic & Clinical Diagnostic: CE-MS applied to forensic toxicological analysis; Franco Taglino, University of Verona, Department of Medicine & Public Health, Section of Forensic Medicine, Policlinico G.B. Rossi, Vernoa Italy
CE for Complex Analyses in Clinical Biochemistry; David Perrett, William Harvey Research Institute, Barts & the London School of Medicine & Dentistry, London UK
ROOM RESERVATIONS:
A room block is reserved at the Boston Park Plaza Hotel for Symposium delegates at the special group rate of $259.00 for single or double occupancy. The cut off date for booking is Sept 9 2009. For more information on booking a room at the Boston Park Plaza Hotel please click below:
http://www.casss.org/displaycommon.cfm?an=1&subarticlenbr=240&convnbr=6003&showmember=5773433
PLEASE VISIT ADDITIONAL CASSS MEETINGS:
CASSS Webinar - Sept 01 2009 - http://casss.org/displayconvention.cfm?conventionnbr=7089
Mass Spec - Sept 15-18 2009 - Philadelphia PA - http://www.casss.org/displayconvention.cfm?conventionnbr=6002
IICS - Sept 21-24 2009 - Dublin Ireland - http://www.casss.org/displayconvention.cfm?conventionnbr=5974
CE Pharm - Oct 11-15 2009 - Boston MA - http://www.casss.org/displayconvention.cfm?conventionnbr=6003
MSB - Oct 18-22 2009 - Dalian China - http://www.casss.org/displayconvention.cfm?conventionnbr=5806
WCBP - Jan 24-27 2010 - Washington DC - http://www.casss.org/displayconvention.cfm?conventionnbr=6690
HPLC - June 19-24 2010 - Boston MA - http://www.casss.org/displayconvention.cfm?conventionnbr=6136
About CASSS:
CASSS (California Separation Science Society) is the premier nonprofit scientific society of over 4,000 industry, academic and public sector professionals in the field of separation science. The society provides forums for disseminating information and discussions among industry, academic and regulatory professionals, involving the development and applications of separation science. CASSS aspires to become the global leader for communicating the development of technology and applications in separation and related sciences.
SOURCE:
CASSS
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08-24-2009 : BioWorld Today Releases New Report: Market-Leading Biotech Drugs Report 2009
BIOWORLD TODAY RELEASES NEW REPORT: MARKET-LEADING BIOTECHNOLOGY DRUGS REPORT 2009
-- 110 pages -- Includes the history, trends, value & projection of the biotech drug therapeutics market
-- Covers revenue & company valuations trends
-- Delivers focused, nimble, efficient, meticulous, precise & value-packed details
http://www.bioworld.com/servlet/com.accumedia.web.Dispatcher?next=S09447_8532
Atlanta GA USA -- Medical Industry E-Mail News Service™ -- Aug 24 2009 -- The publishers of BioWorld Today have just released "Market-Leading Biotechnology Drugs Report 2009: Blockbuster Dynamics in an Ailing Economy," giving you the insight needed to assess, and access, the dynamics that facilitate success in the biotech market.
With the Market-Leading Biotechnology Drugs Report 2009, you will be able to determine:
Which new technology is ordained to lead the fight against disease in the 21st century?
Which drugmakers are projected to comprise the new list of large-cap biotechs in 2015?
What are the 41 drugs that accounted for $35 billion in 2008 revenue that will lose patent exclusivity through 2012?
Which Big Biotech is undergoing FOB competition before its patents even expire, putting $4 billion in sales at risk?
Which biotech drug has the potential to be the first-ever drug to generate $10 billion in annual revenue?
Industry data covered in this report includes comparative coverage of the top pharmaceutical drugs, leading generics companies, and extensive industry statistics for major aspects of the drug development market, including financings, patent expirations, revenue projections, product approvals, FDA submissions and drugs in development.
"No matter what happens with health care reform, federal budgets, patent legislation, recession, or generics, the Holy Grail in biotech and pharma remains 'The Drug,'" says Managing Editor Michael Harris. "Significant importance must be assigned to venture capital funds as biotech's Fountain of Youth, but ultimately, the drugs are the Alpha and Omega in this crucial equation and, arguably, the Most Important Industry on Earth."
CHARTS & TABLES INCLUDE:
Generics company rankings
Clinical trials candidates
Revenue
FDA drug approvals history
Top pharma companies
INFORMATION AVAILABLE ONLINE:
To view the table of contents, samples pages, and to obtain ordering information, please visit:
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08-20-2009 : Prostate Cancer Foundation Funding For Bone Metastasis Research Supports New Drug To Improve Lives Of Prostate Cancer Patients
PROSTATE CANCER FOUNDATION FUNDING FOR BONE METASTASIS RESEARCH
SUPPORTS NEW DRUG TO IMPROVE LIVES OF PROSTATE CANCER PATIENTS
-- Denosumab, increasing bone density & cutting fracture risk in prostate cancer survivors, is one example of promising developments
http://www.pcf.org
Santa Monica CA USA -- Medical Industry E-Mail News Service™ -- Aug 20 2009 -- Twice-yearly intravenous infusion with denosumab, a new targeted therapy to stop bone loss, increased bone density and prevented spinal fractures in men receiving androgen-deprivation therapy for prostate cancer.
The report from an international research study, the first to document reduced fracture risk in men receiving the hormone-blocking treatment, was published today in the print edition of the New England Journal of Medicine (NEJM). Both fundamental research on rank ligand (RANKL) in prostate cancer bone metastasis |